MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-03-03 for CONVATEC NATURA DURAHESIVE WAFER REF 413183 413183 manufactured by Convatec.
[17374357]
Wafer adhesive frequently fails permitting intestinal material access to skin and clothing. This seemingly minor problem can limit one's travel even short distances. The interval between application and leakage varies from hours to weeks. I suspect the problem stems from one or both of the following because as used this product for many years, it has occurred only in the last several months: 1-change in formulation - greater percentage of water-soluble material in the adhesvie or an unevenness of adhesive application.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1038206 |
| MDR Report Key | 691850 |
| Date Received | 2006-03-03 |
| Date of Report | 2006-03-03 |
| Date of Event | 2005-11-01 |
| Date Added to Maude | 2006-03-28 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONVATEC NATURA DURAHESIVE WAFER |
| Generic Name | ILEOSTOMY WAFER 32MM X 15MN |
| Product Code | FON |
| Date Received | 2006-03-03 |
| Model Number | REF 413183 |
| Catalog Number | 413183 |
| Lot Number | SH06807 |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 680989 |
| Manufacturer | CONVATEC |
| Manufacturer Address | * PRINCETON NJ 08543 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-03-03 |