MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-08 for MEDLINE MSG1070 manufactured by Medline.
[85606583]
Technician opened medline sensicare gloves size 7 and discovered them to have brown spotting on left hand. Item# msg1070, lot# 703934540470-5. Complaint reference# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072023 |
| MDR Report Key | 6851355 |
| Date Received | 2017-09-08 |
| Date of Report | 2017-09-06 |
| Date of Event | 2017-09-01 |
| Date Added to Maude | 2017-09-08 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | PHARMACIST |
| 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 | MEDLINE |
| Generic Name | SENSICARE GLOVES |
| Product Code | LZC |
| Date Received | 2017-09-08 |
| Model Number | MSG1070 |
| Lot Number | 703934540470-5 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-08 |