MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2010-07-15 for SUR-FIT NATURA DURAHESIVE MOLDABLE BARRIER 411804 manufactured by Convatec.
[1599612]
Reported by the complainant as follows: customer was sitting watching tv when he noticed his colostomy bag was full of blood. He attempted to stop the bleeding without success, so called for an ambulance. In the er, the doctor could not find a laceration or see where the bleeding was coming from. They cut out a new wafer larger than the stoma and applied. Currently, he has exposed skin around the stoma. I reviewed the use of moldable technology and found he has not been rolling the wafer back to fit; just putting it on as it comes out of the package. I instructed in the correct procedure and to keep the skin clean and dry around the stoma and to follow up with his personal physician. The bleeding continued even after discontinuing use of the moldable skin barrier. On at least 3 different occasions, since the original event, the stoma was sutured; however, the bleeding persisted. On (b) (6) 2010, the end user had surgery on his stoma; although he is not certain what was done, he said they were trying to reduce stoma size.
Patient Sequence No: 1, Text Type: D, B5
[8561311]
(b) (4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243969-2010-00029 |
| MDR Report Key | 1762464 |
| Report Source | 04,07 |
| Date Received | 2010-07-15 |
| Date of Report | 2009-10-29 |
| Date of Event | 2009-10-29 |
| Date Mfgr Received | 2009-10-29 |
| Date Added to Maude | 2010-07-22 |
| 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 | 0 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUR-FIT NATURA DURAHESIVE MOLDABLE BARRIER |
| Generic Name | APPLIANCE, COLOSTOMY, DISPOSABLE |
| Product Code | EZS |
| Date Received | 2010-07-15 |
| Model Number | NA |
| Catalog Number | 411804 |
| Lot Number | 9B46623 |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC |
| Manufacturer Address | 200 HEADQUARTERS PARK DR. SKILLMAN NJ 08558 US 08558 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-07-15 |