MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2005-03-11 for SUR-FIT NATURA STOMAHESIVE FLEXIBLE SKIN BARRIER * 125259 manufactured by Convatec.
[374287]
In 2004 customer emptied ostomy pouch, it was full of blood and stoma was cut. The cut was ~1/4-1/2" in length. Relative drove him to the emergency room where the er md applied silver nitrate to the cut to stop the bleeding. Customer was instructed to cut a bigger opening in the ostomy wafer to accomodate stoma. Customer was subsequently switched to another convatec ostomy wafer and 2 months later customer has reported that customer has had no more incidences of stoma being cut.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1049092-2005-00007 |
| MDR Report Key | 580732 |
| Report Source | 04 |
| Date Received | 2005-03-11 |
| Date of Report | 2005-03-10 |
| Date of Event | 2004-03-01 |
| Date Mfgr Received | 2004-04-14 |
| Device Manufacturer Date | 2001-06-01 |
| Date Added to Maude | 2005-03-15 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | ADRIENNE MCNALLY |
| Manufacturer Street | 200 HEADQUATERS PARK DR. |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUR-FIT NATURA STOMAHESIVE FLEXIBLE SKIN BARRIER |
| Generic Name | OSTOMY WAFER |
| Product Code | EZS |
| Date Received | 2005-03-11 |
| Model Number | * |
| Catalog Number | 125259 |
| Lot Number | 1F47396 |
| 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 | 570590 |
| Manufacturer | CONVATEC |
| Manufacturer Address | 200 HEADQUATERS PARK DRIVE SKILLMANRO NJ 08558 US |
| Baseline Brand Name | SURFIT NATURA STOMAHESIVE FLEXIBLE |
| Baseline Generic Name | SKIN BARRIER |
| Baseline Model No | NA |
| Baseline Catalog No | 125259 |
| Baseline Shelf Life Contained | Y |
| 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 | 2005-03-11 |