MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-07 for PREMIERPRO PLUS NITRILE EXAM GLOVES manufactured by Sps Global.
| Report Number | 8892584 |
| MDR Report Key | 8892584 |
| Date Received | 2019-08-07 |
| Date of Report | 2019-08-05 |
| Date of Event | 2019-06-01 |
| Date Facility Aware | 2019-06-01 |
| Report Date | 2019-08-05 |
| Date Reported to FDA | 2019-08-05 |
| Date Reported to Mfgr | 2019-07-01 |
| Date Added to Maude | 2019-08-14 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PREMIERPRO PLUS NITRILE EXAM GLOVES |
| Generic Name | EXAM GLOVES |
| Product Code | LZC |
| Date Received | 2019-08-07 |
| Lot Number | MTH11-03 S 5062 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPS GLOBAL |
| Manufacturer Address | CHARLOTTE NC US |
| Brand Name | PREMIERPRO PLUS NITRILE EXAM GLOVES |
| Generic Name | EXAM GLOVES |
| Product Code | LZC |
| Date Received | 2019-08-07 |
| Lot Number | MTH11-03 S 5062 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | SPS GLOBAL |
| Manufacturer Address | CHARLOTTE NC US |
| Brand Name | PREMIERPRO PLUS NITRILE EXAM GLOVES |
| Generic Name | EXAM GLOVES |
| Product Code | LZC |
| Date Received | 2019-08-07 |
| Lot Number | MTH11-03 S 5062 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | SPS GLOBAL |
| Manufacturer Address | CHARLOTTE NC US |
| Brand Name | PREMIERPRO PLUS NITRILE EXAM GLOVES |
| Generic Name | EXAM GLOVES |
| Product Code | LZC |
| Date Received | 2019-08-07 |
| Lot Number | MTI03-36 L 5064 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 4 |
| Device Event Key | 0 |
| Manufacturer | SPS GLOBAL |
| Manufacturer Address | CHARLOTTE NC US |
| Brand Name | PREMIERPRO PLUS NITRILE EXAM GLOVES |
| Generic Name | EXAM GLOVES |
| Product Code | LZC |
| Date Received | 2019-08-07 |
| Lot Number | MTI03-38 M 5063 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 5 |
| Device Event Key | 0 |
| Manufacturer | SPS GLOBAL |
| Manufacturer Address | CHARLOTTE NC US |
| Brand Name | PREMIERPRO PLUS NITRILE EXAM GLOVES |
| Generic Name | EXAM GLOVES |
| Product Code | LZC |
| Date Received | 2019-08-07 |
| Lot Number | MTI03-40 S 5062 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 6 |
| Device Event Key | 0 |
| Manufacturer | SPS GLOBAL |
| Manufacturer Address | CHARLOTTE NC US |
| Brand Name | PREMIERPRO PLUS NITRILE EXAM GLOVES |
| Generic Name | EXAM GLOVES |
| Product Code | LZC |
| Date Received | 2019-08-07 |
| Lot Number | MTI01-20 S 5062 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 7 |
| Device Event Key | 0 |
| Manufacturer | SPS GLOBAL |
| Manufacturer Address | CHARLOTTE NC US |
| Brand Name | PREMIERPRO PLUS NITRILE EXAM GLOVES |
| Generic Name | EXAM GLOVES |
| Product Code | LZC |
| Date Received | 2019-08-07 |
| Lot Number | MTI03-39 M 5063 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 8 |
| Device Event Key | 0 |
| Manufacturer | SPS GLOBAL |
| Manufacturer Address | CHARLOTTE NC US |
| Brand Name | PREMIERPRO PLUS NITRILE EXAM GLOVES |
| Generic Name | EXAM GLOVES |
| Product Code | LZC |
| Date Received | 2019-08-07 |
| Lot Number | MTI03-35 S 5062 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 9 |
| Device Event Key | 0 |
| Manufacturer | SPS GLOBAL |
| Manufacturer Address | CHARLOTTE NC US |
| Brand Name | PREMIERPRO PLUS NITRILE EXAM GLOVES |
| Generic Name | EXAM GLOVES |
| Product Code | LZC |
| Date Received | 2019-08-07 |
| Lot Number | MTH11-04 XL 5065 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 10 |
| Device Event Key | 0 |
| Manufacturer | SPS GLOBAL |
| Manufacturer Address | CHARLOTTE NC US |
| Brand Name | PREMIERPRO PLUS NITRILE EXAM GLOVES |
| Generic Name | EXAM GLOVES |
| Product Code | LZC |
| Date Received | 2019-08-07 |
| Lot Number | MTH10-04 S 5062 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 11 |
| Device Event Key | 0 |
| Manufacturer | SPS GLOBAL |
| Manufacturer Address | CHARLOTTE NC US |
| Brand Name | PREMIERPRO PLUS NITRILE EXAM GLOVES |
| Generic Name | EXAM GLOVES |
| Product Code | LZC |
| Date Received | 2019-08-07 |
| Lot Number | MTH10-04 S 5062 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 12 |
| Device Event Key | 0 |
| Manufacturer | SPS GLOBAL |
| Manufacturer Address | CHARLOTTE NC US |
| Brand Name | PREMIERPRO PLUS NITRILE EXAM GLOVES |
| Generic Name | EXAM GLOVES |
| Product Code | LZC |
| Date Received | 2019-08-07 |
| Lot Number | MTH10-05 L 5064 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 13 |
| Device Event Key | 0 |
| Manufacturer | SPS GLOBAL |
| Manufacturer Address | CHARLOTTE NC US |
| Brand Name | PREMIERPRO PLUS NITRILE EXAM GLOVES |
| Generic Name | EXAM GLOVES |
| Product Code | LZC |
| Date Received | 2019-08-07 |
| Lot Number | MTH05-12 M 5063 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 14 |
| Device Event Key | 0 |
| Manufacturer | SPS GLOBAL |
| Manufacturer Address | CHARLOTTE NC US |
| Brand Name | PREMIERPRO PLUS NITRILE EXAM GLOVES |
| Generic Name | EXAM GLOVES |
| Product Code | LZC |
| Date Received | 2019-08-07 |
| Lot Number | MTH05-12 L 5064 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 15 |
| Device Event Key | 0 |
| Manufacturer | SPS GLOBAL |
| Manufacturer Address | CHARLOTTE NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-07 |