MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-12-11 for SURE FIT 00003-0225-22 manufactured by Convatec, Div. Of E.r. Squibbs & Sons, Inc..
[21700213]
Irrigation sleeve did not remain attached to the flexible flange. This has happened with several boxes of each product purchased in two different states.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1007911 |
| MDR Report Key | 28607 |
| Date Received | 1995-12-11 |
| Date of Report | 1995-12-08 |
| Date of Event | 1995-11-01 |
| Date Added to Maude | 1995-12-13 |
| 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 | 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 | SURE FIT |
| Generic Name | SURE FIT |
| Product Code | EXD |
| Date Received | 1995-12-11 |
| Catalog Number | 00003-0225-22 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 29562 |
| Manufacturer | CONVATEC, DIV. OF E.R. SQUIBBS & SONS, INC. |
| Manufacturer Address | GREENSBORO NC 27409 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-12-11 |