MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-01-14 for GLOVE, EXAM, NITRILE manufactured by Bisma.
[5384416]
A rusted metal clip attached to one of the gloves was found in the box of newly opened gloves. Item description: glove, exam, nitrile, med, ltx-free, powder-free, textured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5040246 |
| MDR Report Key | 4438034 |
| Date Received | 2015-01-14 |
| Date of Report | 2015-01-14 |
| Date Added to Maude | 2015-01-22 |
| 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 | UNKNOWN |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | GLOVE, EXAM, NITRILE |
| Product Code | LYY |
| Date Received | 2015-01-14 |
| Lot Number | 14461-261403 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BISMA |
| Manufacturer Address | INDIANAPOLIS IN 46268 US 46268 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-01-14 |