MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2003-09-30 for SUR-FIT NATURA DURAHESIVE MOLDABLE CONVEX * 404592 manufactured by Convatec.
[302209]
Ostomy pt had family member apply an ostomy wafer around stoma. Family member ran finger around stoma to make sure barrier was well-adhered to peri-stomal skin. After 30 minutes, pt noticed stoma was bleeding. Pt went to emergency room to get their stoma sutured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1049092-2003-00001 |
| MDR Report Key | 486686 |
| Report Source | 01 |
| Date Received | 2003-09-30 |
| Date of Report | 2003-09-29 |
| Date of Event | 2003-09-19 |
| Date Mfgr Received | 2003-09-22 |
| Device Manufacturer Date | 2003-04-01 |
| Date Added to Maude | 2003-10-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | ADRIENNE MCNALLY |
| Manufacturer Street | 200 HEADQUARTERS PARK DRIVE |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9089042630 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUR-FIT NATURA DURAHESIVE MOLDABLE CONVEX |
| Generic Name | OSTOMY WAFER |
| Product Code | EZS |
| Date Received | 2003-09-30 |
| Model Number | * |
| Catalog Number | 404592 |
| Lot Number | 3D68002 |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 475572 |
| Manufacturer | CONVATEC |
| Manufacturer Address | 200 HEADQUARTERS PARK DRIVE SKILLMAN NJ 08558 US |
| Baseline Brand Name | SUR-FIT NATURA DURAHESIVE MOLDABLE CONVEX |
| Baseline Generic Name | OSTOMY WAFER |
| Baseline Model No | NA |
| Baseline Catalog No | 404592 |
| Baseline ID | NA |
| Baseline Device Family | TWO-PIECE OSTOMY APPLIANCE |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2003-09-30 |