MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-20 for HALYARD STERLING 50706 manufactured by Halyard Health, Inc..
[86756527]
Patient Sequence No: 1, Text Type: N, H10
[86756528]
Halyard sterling nitrile powder free exam gloves, size small, ref 50706 have visible 'weak' areas on one or more fingers of the gloves. Not every glove is affected although a majority of random gloves throughout the box have these 'weak' areas and several create holes or tear as user is inserting hand into the glove. Currently have (2) boxes of this same lot affected. Currently no issues reported with the other sizes of halyard gloves.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6878539 |
| MDR Report Key | 6878539 |
| Date Received | 2017-09-20 |
| Date of Report | 2017-09-07 |
| Date of Event | 2017-08-29 |
| Report Date | 2017-09-07 |
| Date Reported to FDA | 2017-09-07 |
| Date Reported to Mfgr | 2017-09-07 |
| Date Added to Maude | 2017-09-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | 3 |
| Brand Name | HALYARD STERLING |
| Generic Name | SPECIALTY -TESTED FOR USE WITH CHEMOTHERAPY - PATIENT EXAMINATION GLOVE |
| Product Code | LZC |
| Date Received | 2017-09-20 |
| Catalog Number | 50706 |
| Lot Number | SP7143ZZZ_08AX |
| Operator | NURSE |
| Device Availability | * |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HALYARD HEALTH, INC. |
| Manufacturer Address | 5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-20 |