MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor,other report with the FDA on 2020-02-14 for PUREWICK FEMALE EXTERNAL PWF030F manufactured by C.r. Bard, Inc. (covington) -1018233.
[179489912]
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[179489913]
It was reported that the patient stated the machine was just suctioning air and caused irritation. It also caused sores in her vaginal area. She thought it was a combination of the urine and the rubber which caused the irritation. She stated she avoided using the machine due to this. The patient also stated the patient hose kept popping of. It was unknown if the patient received intervention for the sores.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01066 |
| MDR Report Key | 9712493 |
| Report Source | CONSUMER,DISTRIBUTOR,OTHER |
| Date Received | 2020-02-14 |
| Date of Report | 2020-02-19 |
| Date Mfgr Received | 2020-02-18 |
| Date Added to Maude | 2020-02-14 |
| 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 | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PUREWICK FEMALE EXTERNAL |
| Generic Name | PURE WICK |
| Product Code | NZU |
| Date Received | 2020-02-14 |
| Catalog Number | PWF030F |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Address | 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-14 |