MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-12-24 for RELIAFIT * manufactured by Bioderm, Inc..
[5467635]
Two skin alterations or skin tears noted on the ventral and dorsal sides of penis, due to usage of reliafit trial catheters. The patient was complaining of discomfort with the catheter which was identified by patient's wife (when previously there had been no problems with function or complaints even after assessment in am). The reliafit was removed and a new reliafit placed. The new catheter leaked, and when the nurse attempted to remove the second reliafit using the suggested detachol solution for removal, skin came off with sticky part of tape.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4603426 |
| MDR Report Key | 4603426 |
| Date Received | 2014-12-24 |
| Date of Report | 2014-12-24 |
| Date of Event | 2014-12-18 |
| Report Date | 2014-12-24 |
| Date Reported to FDA | 2014-12-24 |
| Date Reported to Mfgr | 2015-03-16 |
| Date Added to Maude | 2015-03-16 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELIAFIT |
| Generic Name | DEVICE, PASTE-ON FOR INCONTINANCE, NON-STERILE |
| Product Code | NOA |
| Date Received | 2014-12-24 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIODERM, INC. |
| Manufacturer Address | 12320 73RD COURT NORTH LARGO FL 33773 US 33773 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-24 |