MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-11 for BOSMA ENTERPRISES 72-10501 manufactured by Bosma Enterprises.
[4759692]
A nurse put on a new glove out of the box and it contained an unknown oily substance with a black substance mixed in. The glove was then removed from use. Will send to manufacturer for analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5038201 |
| MDR Report Key | 4096458 |
| Date Received | 2014-09-11 |
| Date of Report | 2014-09-10 |
| Date of Event | 2014-09-08 |
| Date Added to Maude | 2014-09-18 |
| 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 | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Brand Name | BOSMA ENTERPRISES |
| Generic Name | SIZE SMALL NITRILE EXAM GLOVES, HIGH FIVE PERFORMANCE GLOVES |
| Product Code | LYY |
| Date Received | 2014-09-11 |
| Returned To Mfg | 2014-09-12 |
| Model Number | 72-10501 |
| Lot Number | 15063-261406 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSMA ENTERPRISES |
| Manufacturer Address | INDIANAPOLIS IN 46268 US 46268 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-11 |