MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2018-02-14 for PUREWICK FEMALE EXTERNAL CATHETER PWF030 manufactured by Purewick Corporation ? 3012224959.
[100023591]
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
[100023592]
It was reported that the patient experienced two urinary tract infections over the course of two months using the purewick external catheter. The complainant reported that the patient was in the hospital and receiving intravenous antibiotics.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2018-00447 |
| MDR Report Key | 7269750 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2018-02-14 |
| Date of Report | 2018-03-09 |
| Date Mfgr Received | 2018-03-07 |
| Device Manufacturer Date | 2017-09-12 |
| Date Added to Maude | 2018-02-14 |
| 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 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| 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 | 3 |
| Brand Name | PUREWICK FEMALE EXTERNAL CATHETER |
| Generic Name | PUREWICK FEMALE EXTERNAL |
| Product Code | NNW |
| Date Received | 2018-02-14 |
| Catalog Number | PWF030 |
| Lot Number | PWBW0043 |
| 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 | PUREWICK CORPORATION ? 3012224959 |
| Manufacturer Address | 203 GILLESPIE WAY EL CAJON CA 92020 US 92020 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-02-14 |