MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-12 for PUREWICK FEMALE EXTERNAL CATHETER PWF030 manufactured by Purewick Corporation ? 3012224959.
[100148339]
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[100148340]
It was initially reported that the patient experienced perineal bleeding as a result of the suction on the purewick being too high. Per additional information received, the patient did not experience perineal bleeding but redness around the area. No medical intervention was required. The complainant reported that the pressure was set at 160mm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2018-00429 |
| MDR Report Key | 7264793 |
| Date Received | 2018-02-12 |
| Date of Report | 2018-03-01 |
| Date Mfgr Received | 2018-02-20 |
| Date Added to Maude | 2018-02-12 |
| 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 | AMY GRAVLEY |
| 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 |
| Product Code | NNW |
| Date Received | 2018-02-12 |
| 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 | 2018-02-12 |