MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-01-15 for STOMAHESIVE PASTE * 183910 manufactured by Convatec Div Of Squibb.
[350532]
Itching on skin. Pt has to clean paste off and the area; left it exposed to air. This product was discontinued and replaced with another product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1031023 |
| MDR Report Key | 511116 |
| Date Received | 2004-01-15 |
| Date of Report | 2003-12-10 |
| Date of Event | 2003-12-01 |
| Date Added to Maude | 2004-02-13 |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STOMAHESIVE PASTE |
| Generic Name | PROTECTIVE SKIN BARRIER |
| Product Code | EZR |
| Date Received | 2004-01-15 |
| Model Number | * |
| Catalog Number | 183910 |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 500083 |
| Manufacturer | CONVATEC DIV OF SQUIBB |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-01-15 |