MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-03-14 for STOMAHESIVE WITH SUR-FIT FLANGE, 1 3/4" manufactured by Convatec Div. E. R. Squibb And Sons, Inc..
[6968]
Pt uses flange wafers (1 3/4"). Pt states that this lot did not stick to skin and believes the glue is faulty. Pt tried another box with the same lot number and it also did not stick to the skin and the pt had spillage from appliance.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1001051 |
| MDR Report Key | 11996 |
| Date Received | 1994-03-14 |
| Date of Report | 1994-03-10 |
| Date of Event | 1994-02-01 |
| Date Added to Maude | 1994-03-15 |
| 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 | 0 |
| Reporter Occupation | PHARMACIST |
| 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 WITH SUR-FIT FLANGE, 1 3/4" |
| Product Code | EZR |
| Date Received | 1994-03-14 |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 11996 |
| Manufacturer | CONVATEC DIV. E. R. SQUIBB AND SONS, INC. |
| Manufacturer Address | GREENSBORO NC 27409 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-03-14 |