MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-05-02 for SUR-FIT NATURA DURAHESIVE MOLDABLE CONVEX * 401921 manufactured by Convatec, A Bristol-myers Squibb Co.
[17031908]
A patient was in the or for vascular procedure, femoral/femoral bypass. The patient was to be prepped from the nipples to the heels. The patient had a colostomy. A sterile colostomy bag was requested. A package was opened by the circulator nurse and placed on the sterile field. When the colostomy bags in the storage area was checked at the end of the case it was discovered that both sterile and non sterile colostomy bags were present with similiar packaging. Sterile bags were marked sterile - non sterile bags were not marked - nonsterile.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 599182 |
| MDR Report Key | 599182 |
| Date Received | 2005-05-02 |
| Date of Report | 2005-05-02 |
| Date of Event | 2005-04-11 |
| Report Date | 2005-05-02 |
| Date Reported to FDA | 2005-05-02 |
| Date Added to Maude | 2005-05-06 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUR-FIT NATURA DURAHESIVE MOLDABLE CONVEX |
| Generic Name | DRAINABLE POUCH STOMAHESIVE WAFER |
| Product Code | EZS |
| Date Received | 2005-05-02 |
| Model Number | * |
| Catalog Number | 401921 |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 589010 |
| Manufacturer | CONVATEC, A BRISTOL-MYERS SQUIBB CO |
| Manufacturer Address | 200 HEADQUARTERS PARK DR SKILLMAN NJ 08558 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-05-02 |