MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-11-12 for 72-10502 manufactured by Bosma Enterprises.
[4992800]
Foreign object, which appears to be a rusty washer, was found by staff inside the box of nitrile exam gloves. The object was stuck to the outside of one of the gloves inside the box. There was also a rusty residue from the washer on the glove. Will send to manufacturer for analysis. See scanned page.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5039045 |
| MDR Report Key | 4253536 |
| Date Received | 2014-11-12 |
| Date of Report | 2014-11-12 |
| Date of Event | 2014-11-07 |
| Date Added to Maude | 2014-11-18 |
| 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 |
| 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 | SIZE MEDIUM NITRILE EXAM GLOVES HIGH FIVE PERFORMANCE GLOVES |
| Product Code | LYY |
| Date Received | 2014-11-12 |
| Model Number | 72-10502 |
| Catalog Number | 72-10502 |
| Lot Number | 15073-261407 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2014-11-12 |