MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-12-11 for ACTIVE LIFE ONE PIECE OSTOMY APPLIANCE 22771 manufactured by .
[19527478]
Ostomy appliance failed several times to adhere causing severe tissue breakdown from leakage of contents on the surrounding skin. Appliance was active life one piece system, model # 22771.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5014089 |
| MDR Report Key | 1564891 |
| Date Received | 2009-12-11 |
| Date of Report | 2009-12-11 |
| Date of Event | 2009-12-07 |
| Date Added to Maude | 2010-01-04 |
| 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 |
| 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 | ACTIVE LIFE ONE PIECE OSTOMY APPLIANCE |
| Generic Name | NONE |
| Product Code | EZS |
| Date Received | 2009-12-11 |
| Model Number | 22771 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-12-11 |