MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-01-23 for GLOVE, EXAM, NITRILE manufactured by Bosma Industries For The Blind.
[5399692]
An oily substance was found on the gloves of a newly opened package of gloves.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5040459 |
| MDR Report Key | 4466339 |
| Date Received | 2015-01-23 |
| Date of Report | 2015-01-23 |
| Date of Event | 2014-09-26 |
| Date Added to Maude | 2015-01-30 |
| 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 |
| Health Professional | 0 |
| 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 |
| Brand Name | GLOVE, EXAM, NITRILE |
| Generic Name | GLOVE, EXAM, NITRILE |
| Product Code | LYY |
| Date Received | 2015-01-23 |
| Lot Number | 15056-261405 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSMA INDUSTRIES FOR THE BLIND |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-01-23 |