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.
[369869]
Customer had been using product since 1976 had developed rash underneath the wfer that soon spread over a large portion of the body. Customer as seen by family doctor and two different dermatologists. Skin biopsies were performed but did not result in a positive diagnosis. Three possible diagnoses: 1) id reaction for contact dermatities, 2) pityriasis rosea, or 3) suspected drug reactin were identified but never confirmed. Investgation closed in 04/1997 when doctors decided that it would be impossible to determine if the allergic reaction was linked to product use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1049092-2005-00024 |
| MDR Report Key | 597506 |
| Report Source | 04 |
| Date Received | 2005-04-30 |
| Date of Report | 2005-04-29 |
| Date of Event | 1997-03-03 |
| Date Mfgr Received | 1997-03-03 |
| 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 DR |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9089042630 |
| 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 | OSTEOMY APPLIANCE |
| Product Code | EZS |
| 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 | 587334 |
| 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 |