MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-08 for PREMIER PRO PLUS 5063 manufactured by Svs Llc.
[144420049]
Clinical area reported that premier pro plus non sterile glove size medium (5063) have fine glitter on them that rubs off when touched. Lot number: ceh-10-06, manufactured: 2018-10. Our system-wide materials management checked multiple boxes w/ this lot # and all had the fine glitter. The following action was taken within our system: based on our current stock, we have estimated that (b)(4) boxes of this lot number have been distributed throughout our hospital system. We identified potentially 79 different locations outside the supply who could have these gloves. Notifications were sent to the other locations for these to be pulled and returned to the main warehouse we provided a limited substitute for this glove with another product and ordered (b)(4) of the premier glove (different lot #) to be delivered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8590804 |
| MDR Report Key | 8590804 |
| Date Received | 2019-05-08 |
| Date of Report | 2019-04-09 |
| Date of Event | 2019-02-27 |
| Report Date | 2019-04-19 |
| Date Reported to FDA | 2019-04-19 |
| Date Reported to Mfgr | 2019-05-08 |
| Date Added to Maude | 2019-05-08 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | PREMIER PRO PLUS |
| Generic Name | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE |
| Product Code | LZA |
| Date Received | 2019-05-08 |
| Model Number | 5063 |
| Lot Number | CEH 10-06 |
| Device Availability | * |
| 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 | 2019-05-08 |