MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-14 for PREMIERPRO PLUS manufactured by Svs Llc.
[174880214]
When nurse was putting on gloves, she felt debris in the tip of the glove on the middle finger, removed the glove and took the box of gloves out of service. Unable to determine the source of the debris.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9585991 |
| MDR Report Key | 9585991 |
| Date Received | 2020-01-14 |
| Date of Report | 2019-12-26 |
| Date of Event | 2019-12-16 |
| Report Date | 2019-12-26 |
| Date Reported to FDA | 2019-12-26 |
| Date Reported to Mfgr | 2020-01-14 |
| Date Added to Maude | 2020-01-14 |
| 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 | PREMIERPRO PLUS |
| Generic Name | POWDERED LATEX SURGEON'S GLOVES |
| Product Code | KGO |
| Date Received | 2020-01-14 |
| Lot Number | MTH11-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 DA |
| 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 | 2020-01-14 |