MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-06-24 for SUR-FIT FLEXIBLE * manufactured by Convatec.
[57924]
Pt reports to be a self employed technically trained colostomate. During the evening of may 21, 1997 he replaced his prosthesis; a routine occurrence. On the morning of may 22, 1997 he made some business calls; & fortunately returned home for lunch. During that period, the left side of the flange experienced an adhesion failure. In addition to the stench, the exuded feces soiled his clothes. Next time he experiences a similar failure, he may freeze the entire appliance in the condition that is removed from the body, pack it in dry ice and send it to mfr or, may send it to the fda. Requests mfr replace the failed 1 3/4-inch flange with one that has a reasonable probability of functioning effectively.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1011557 |
| MDR Report Key | 100285 |
| Date Received | 1997-06-24 |
| Date of Report | 1997-06-24 |
| Date of Event | 1997-05-22 |
| Date Added to Maude | 1997-06-26 |
| 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 | PATIENT |
| 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 | SUR-FIT FLEXIBLE |
| Generic Name | COLOSTOMY PROSTHESIS |
| Product Code | EZS |
| Date Received | 1997-06-24 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 96129674 |
| ID Number | NDC 0003-0225-27 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 98798 |
| Manufacturer | CONVATEC |
| Manufacturer Address | P.O. BOX 5254 PRINCETON NJ 08543 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-06-24 |