MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-31 for NITRILE EXAM GLOVES 5063 manufactured by Svs Llc.
[134577204]
I have one box of premierpro plus gloves with holes in many of the gloves. Staff pulled 8-10 gloves off of the top, 4 of those had holes in the fingers. I pulled an additional four gloves out of the box, one glove had a hole in a finger.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8292305 |
| MDR Report Key | 8292305 |
| Date Received | 2019-01-31 |
| Date of Report | 2019-01-18 |
| Date of Event | 2019-01-16 |
| Report Date | 2019-01-18 |
| Date Reported to FDA | 2019-01-18 |
| Date Reported to Mfgr | 2019-01-31 |
| Date Added to Maude | 2019-01-31 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 3 |
| Brand Name | NITRILE EXAM GLOVES |
| Generic Name | POLYMER PATIENT EXAMINATION GLOVE |
| Product Code | LZA |
| Date Received | 2019-01-31 |
| Model Number | 5063 |
| Catalog Number | 5063 |
| Lot Number | CEH 09-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SVS LLC |
| Manufacturer Address | 14120 BALLANTYNE CORPORATE PL STE 425 CHARLOTTE NC 28277 US 28277 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-31 |