MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2013-09-23 for SUR-FIT NATURA 2 PC DURAHESIVE CONVEX WAFER 413181 manufactured by Convatec Inc.
[3716075]
End-user reports red irritated area located at the base of the stoma.
Patient Sequence No: 1, Text Type: D, B5
[11192494]
Based on the available info, this event is deemed a serious injury. From a clinical perspective, a causal relationship between the sur-fit natura 2 pc durahesive convex wafer and this event is deemed possible because the product in use is temporarily associated with the skin where the problem occurred. Report states that the box was discarded, therefore, a return sample was not available for lot number identification. No additional event/pt details have been provided to date. A return sample for eval is not expected. Reported to fda on (b)(4), 2013. Note: the actual date of event is unk, as the date used was the date convatec became aware.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1049092-2013-00041 |
| MDR Report Key | 3372992 |
| Report Source | 04,07 |
| Date Received | 2013-09-23 |
| Date of Report | 2013-08-26 |
| Date of Event | 2013-08-26 |
| Date Mfgr Received | 2013-08-26 |
| Date Added to Maude | 2013-09-30 |
| 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 | MARY SZARO |
| Manufacturer Street | 200 HEADQUARTERS PARK DR |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9089042450 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUR-FIT NATURA 2 PC DURAHESIVE CONVEX WAFER |
| Generic Name | PROTECTOR, OSTOMY |
| Product Code | EZS |
| Date Received | 2013-09-23 |
| Model Number | 413181 |
| Catalog Number | 413181 |
| Lot Number | UNK |
| 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 INC |
| Manufacturer Address | 211 AMERICAN AVE. GREENSBORO NC 27409 US 27409 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-23 |