MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2008-12-23 for SUR-FIT NATURA DURAHESIVE SKIN BARRIER W/FLNG 413157 manufactured by Convatec Dr Inc..
[1002237]
Reported by the complainant as follows: customer had to switch to the 70mm wafers and has experienced bleeding circumferentially around the stoma where the flange touched his stoma. On the event date; customer went to the emergency room at hospital where the wound nurse cauterized the stoma to stop the bleeding. Spouse states at 2am this morning; two days later; her husband experienced additional bleeding. She was able to stop the bleeding by wrapping the stoma with gauze and securing it with waterproof tape. She then cut the wafer out to the plastic flange and took end user to his physician. Bleeding has stopped. Md recommended a more appropriately sized water. Reported to the fda in the same month.
Patient Sequence No: 1, Text Type: D, B5
[8203474]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243969-2008-00013 |
| MDR Report Key | 1274762 |
| Report Source | 04,07 |
| Date Received | 2008-12-23 |
| Date of Report | 2008-12-05 |
| Date of Event | 2008-12-03 |
| Date Mfgr Received | 2008-12-05 |
| Date Added to Maude | 2009-01-12 |
| 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 SKIN BARRIER W/FLNG |
| Generic Name | PROTECTOR, OSTOMY |
| Product Code | EZS |
| Date Received | 2008-12-23 |
| Model Number | NA |
| Catalog Number | 413157 |
| Lot Number | 8A45202 |
| 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 DR INC. |
| Manufacturer Address | CARRETERA SANCHEZ, KM 18.2 PARQUE INDUSTRIAL ITABO, S.A. HAINA 33102 DR 33102 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-12-23 |