MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-10-10 for CONVATEC SUREFIT FLEXIBLE NATURA * manufactured by Convatec, Div Of E.r. Squidt & Sons, Inc..
[102319]
Ostomy prosthesis did not adhere to body. Ineffective seal caused feces to soil body, thereby preventing the colostomate from engaging in normal social and physical activity. Rptr states item is being sent to fda because it is important that fda knows what a component of a class i prosthesis is. Flange #1-within 24 hrs the seal separated and did not retain the feces. Flange #2-within 8 hrs the seal separated and did not retain the feces. The nutra is alleged to be an improved product. It is not an effective , not reliable and of a poorer quality than its predecessor. Since mfr letter of december 28,1995, convatec, apparently, had not instituted a quality control impossible to pinpoint why the adherence time with one lot of product will vary from the adherence time obtained with a product from another or the same lot. "that, to me and one versed in the art, says "no quality control. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1012278 |
| MDR Report Key | 125678 |
| Date Received | 1997-10-10 |
| Date of Report | 1997-10-03 |
| Date of Event | 1997-10-01 |
| Date Added to Maude | 1997-10-15 |
| 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 | 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 | CONVATEC SUREFIT FLEXIBLE NATURA |
| Generic Name | STOMA ADHESIVE FLANGE |
| Product Code | EZR |
| Date Received | 1997-10-10 |
| Returned To Mfg | 1997-10-04 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 97068531 |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 123025 |
| Manufacturer | CONVATEC, DIV OF E.R. SQUIDT & SONS, INC. |
| Manufacturer Address | 100 HEADQUARTERS PARK DR S/GILLMAN NJ 08558 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 1 | 1. Other | 1997-10-10 |