MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-03 for PUREWICK FEMALE EXTERNAL CATHETER PWF030 manufactured by Purewick Corporation ? 3012224959.
| Report Number | 1018233-2019-03603 |
| MDR Report Key | 8758127 |
| Date Received | 2019-07-03 |
| Date of Report | 2019-07-24 |
| Date of Event | 2019-05-22 |
| Date Mfgr Received | 2019-07-10 |
| Date Added to Maude | 2019-07-03 |
| 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 | YONIC ANDERSON |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | PUREWICK CORPORATION |
| Manufacturer Street | 203 GILLESPIE WAY |
| Manufacturer City | EL CAJON CA 92020 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92020 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PUREWICK FEMALE EXTERNAL CATHETER |
| Generic Name | PUREWICK DEVICE |
| Product Code | NZU |
| Date Received | 2019-07-03 |
| Catalog Number | PWF030 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PUREWICK CORPORATION ? 3012224959 |
| Manufacturer Address | 203 GILLESPIE WAY EL CAJON CA 92020 US 92020 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-07-03 |