MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-26 for PUREWICK FEMALE EXTERNAL CATHETER PWF030 manufactured by Purewick Corporation ? 3012224959.
[90967829]
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
[90967830]
It was reported that a patient developed a "friction abrasion on the buttock area". The wound ostomy nurse (won) described the abrasions as resembling "suction marks". It was discovered that the device had not been properly placed and the suction was at 200 mmhg. It was unknown when the device was last changed. Immediately following the event, the female external catheter was discontinued. It was replaced the following day after the staff had additional training on the device. The won stated that after two days of the area being treated with an over the counter skin barrier cream, the area in question was almost healed. It was confirmed that the patient was not on a bedpan. The won stated that this was user error and has scheduled additional training with all the staff on the use of this device. The patient was placed on the device on (b)(6) 2017 for 10 days. The history of the patient includes that she is a larger patient, in a vegetative state, and has been in the care of the facility for over a year. Clinical statement: the ifu states to "always use the minimum amount of suction necessary. " regarding placement of the device, the ifu instructs to "gently tuck soft gauze side between separated gluteus and labia. Ensure that the top of the gauze is aligned with the pubic bone. Slowly place legs back together once" the device is positioned. This is to be done after perineal care has been performed. The ifu states that the device should be changed "at least every 8-12 hours. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2017-05510 |
| MDR Report Key | 6982581 |
| Date Received | 2017-10-26 |
| Date of Report | 2017-11-03 |
| Date of Event | 2017-10-03 |
| Date Mfgr Received | 2017-11-01 |
| Date Added to Maude | 2017-10-26 |
| 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 | FEMALE EXTERNAL CATHETER |
| Product Code | NNW |
| Date Received | 2017-10-26 |
| 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 | 2017-10-26 |