MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other, report with the FDA on 2018-03-28 for PUREWICK FEMALE EXTERNAL PWF030 manufactured by Purewick Corporation ? 3012224959.
[103661085]
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
[103661086]
It was reported that the patient developed a "pressure ulcer along the line of the purewick. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2018-00976 |
| MDR Report Key | 7376816 |
| Report Source | COMPANY REPRESENTATIVE,OTHER, |
| Date Received | 2018-03-28 |
| Date of Report | 2018-04-10 |
| Date Mfgr Received | 2018-04-09 |
| Date Added to Maude | 2018-03-28 |
| 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 | 3 |
| Brand Name | PUREWICK FEMALE EXTERNAL |
| Generic Name | PUREWICK |
| Product Code | NNW |
| Date Received | 2018-03-28 |
| 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 | 1. Other | 2018-03-28 |