MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2005-04-30 for SUR-FIT UROSTOMY ACCUSEAL 21926 manufactured by Convatec.
[396625]
Patient has urostomy with stents. Patient was discharged same day; full pouch detached, nearly removing patient's urostomy stents. Customer experienced pain and bleeding from stoma. Stents had been in place since urostomy in 1996. Stents (which are not surtured) are irrigated weekly by relative and replaced every 3 months. Relatives stated that it was nearly time for the stents to be changed. In 1998 customer continued to have slight hematuria and a great deal of pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1049092-2005-00010 |
| MDR Report Key | 597522 |
| Report Source | 04 |
| Date Received | 2005-04-30 |
| Date of Report | 2005-04-29 |
| Date of Event | 1998-07-09 |
| Date Added to Maude | 2005-05-03 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | ADRIENNE MCNALLY |
| Manufacturer Street | 200 HEADQUARTERS 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUR-FIT UROSTOMY ACCUSEAL |
| Generic Name | OSTEOMY APPLIANCE |
| Product Code | EZS |
| Date Received | 2005-04-30 |
| Model Number | NA |
| Catalog Number | 21926 |
| Lot Number | USC-572 |
| 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 | 587350 |
| Manufacturer | CONVATEC |
| Manufacturer Address | 200 HEADQUARTERS PARK DRIVE SKILLMAN NJ 08558 US |
| Baseline Brand Name | SUR-FIT UROSTOMY ACCUSEAL |
| Baseline Generic Name | OSTEOMY APPLIANCE |
| Baseline Model No | NA |
| Baseline Catalog No | 21926 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-04-30 |