MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-05-03 for ADAPT manufactured by Hollister Incorporated Consumer Programs Teams.
[19906269]
I have an ostomy bag which i have worn for approximately 18 years. In the (b)(6) 2010, i started to get red dots on my skin which i attributed to the heat. As time went on, the skin got redder and the tissue began to seep fluid to the point in 2011, i could not wear the bag due to excessive seeping. I contacted my ostomy nurse who tried different products to the point she was at a loss. At that point, i went to a surgeon who initially thought it was my crohn's attacking my skin. He put me on a dose of prednisone and that helped the skin start to clear. Once i tapered of the prednisone, the weeping skin and ulcerations started up again. He then put me on a long regimen of prednisone and had me slowly taper and notify him if the skin started to get worse. At 30mg of prednisone, the skin started to redden and weep again. He then said, i needed to see a dermatologist. Dates of use: (b)(6) 1990 - (b)(6) 2011.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5020505 |
| MDR Report Key | 2081824 |
| Date Received | 2011-05-03 |
| Date of Report | 2011-05-03 |
| Date of Event | 2010-07-30 |
| Date Added to Maude | 2011-05-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADAPT |
| Generic Name | PASTE |
| Product Code | EZR |
| Date Received | 2011-05-03 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLLISTER INCORPORATED CONSUMER PROGRAMS TEAMS |
| Manufacturer Address | 2000 HOLLISTER DR LIBERTYVILLE IL 60048 US 60048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-05-03 |