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 2019-12-27 for PUREWICK FEMALE EXTERNAL PWF030 manufactured by Adaptec Medical Devices Llc 3014271001.
[172825857]
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
[172825858]
It was reported that the wicks do not suction and have caused the customer an uti. It is unknown what medical interventions were given for the uti.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2019-08256 |
| MDR Report Key | 9523228 |
| Report Source | CONSUMER,DISTRIBUTOR,OTHER |
| Date Received | 2019-12-27 |
| Date of Report | 2020-02-21 |
| Date Mfgr Received | 2020-02-10 |
| Date Added to Maude | 2019-12-27 |
| 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 | ADAPTEC MEDICAL DEVICES LLC 3014271001 |
| Manufacturer Street | 260 JAMES JACKSON AVENUE |
| Manufacturer City | CARY NC 27513 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27513 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PUREWICK FEMALE EXTERNAL |
| Generic Name | WICK |
| Product Code | NZU |
| Date Received | 2019-12-27 |
| Catalog Number | PWF030 |
| 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 | ADAPTEC MEDICAL DEVICES LLC 3014271001 |
| Manufacturer Address | 260 JAMES JACKSON AVENUE CARY NC 27513 US 27513 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-12-27 |