MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-06-07 for NUPREP SKIN PREP GEL 10-30 manufactured by D.o. Weaver And Company.
| Report Number | 1718791-2019-00003 |
| MDR Report Key | 8679544 |
| Report Source | CONSUMER |
| Date Received | 2019-06-07 |
| Date of Report | 2019-06-07 |
| Date of Event | 2019-04-30 |
| Date Mfgr Received | 2019-05-08 |
| Date Added to Maude | 2019-06-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. NICHOLAS LEE |
| Manufacturer Street | 565 NUCLA WAY, UNIT B |
| Manufacturer City | AURORA 800119319 |
| Manufacturer Country | US |
| Manufacturer Postal | 800119319 |
| Manufacturer Phone | 3033661804 |
| Manufacturer G1 | D.O. WEAVER AND COMPANY |
| Manufacturer Street | 565 NUCLA WAY, UNIT B |
| Manufacturer City | AURORA 800119319 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 800119319 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUPREP SKIN PREP GEL |
| Generic Name | ABRASIVE SKIN PREPPING GEL |
| Product Code | DRX |
| Date Received | 2019-06-07 |
| Model Number | 10-30 |
| Catalog Number | 10-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | D.O. WEAVER AND COMPANY |
| Manufacturer Address | 565 NUCLA WAY, UNIT B AURORA 800119319 US 800119319 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-06-07 |