MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2005-04-30 for STOMAHESIVE WAFER WITH SUR-FIT FLANGE 25611 manufactured by Convatec.
[379735]
Customer had a history of skin problems (denuded skin) in the peristomal area since oct. 1995. Ub 1997, customer went to remove customer's stomahesive wafer and completely denuded the skin in the peristomal area. Customer was seen by a surgeon who advised to discontinue use of the wafer and not to used any adhesive products. Two weeks later, customer was using an emesis basis taped to abdomen with no skin treatment. Customer had blisters and the surgeon recommended a dermatologist. The dermatologist performed a punch biopsy. Results of the punch biopsy: negative for carcinoma and infection; report indicated "extreme irritation of dermis" there were no signs of malignancy nor allergic reactions. Patch tests were negative which makes it extremely unlikely that the reaction was related to the convatec materials.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1049092-2005-00025 |
| MDR Report Key | 597582 |
| Report Source | 04 |
| Date Received | 2005-04-30 |
| Date of Report | 2005-04-29 |
| Date of Event | 1997-03-26 |
| Date Mfgr Received | 1997-04-16 |
| Date Added to Maude | 2005-05-03 |
| 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 | 0 |
| Manufacturer Contact | ADRIENNE MCNALLY |
| Manufacturer Street | 200 HEADQUARTERS PARK DRIVE |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9099042630 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STOMAHESIVE WAFER WITH SUR-FIT FLANGE |
| Generic Name | OSTOMY WAFER |
| Product Code | EZR |
| Date Received | 2005-04-30 |
| Model Number | NA |
| Catalog Number | 25611 |
| Lot Number | UNK |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 587412 |
| Manufacturer | CONVATEC |
| Manufacturer Address | 200 HEADQUARTERS PARK DRIVE SKILLMAN NJ 08558 US |
| Baseline Brand Name | STOMAHESIVE WAFER WITH SUR-FIT FLANGE |
| Baseline Generic Name | OSTEOMY APPLIANCE |
| Baseline Model No | NA |
| Baseline Catalog No | 25611 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-04-30 |