MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,07 report with the FDA on 2013-09-30 for SUR-FIT NATURA 2 PC - DURAHESIVE CONVEX WAFER 413177 manufactured by Convatec, Inc..
[15174457]
End user reported that approximately two weeks ago, she developed red, irritated, broken skin under the mass at the 6 o'clock position where stoma is retracted.
Patient Sequence No: 1, Text Type: D, B5
[15600180]
Based on the available info, this event is deemed a serious injury. The end user states she cleans her skin with ivory soap and water, rinses, dries and then applies powder. She applies eakin and then the appliance. The end user stated that she will follow up with a wound care nurse. From a clinical perspective, a causal relationship between the sur-fit natura 2 pc durahesive convex wafer and this event is deemed possible because product use is temporally associated with the skin where the problem occurred. No additional pt/event details have been provided to date. Should additional info becomes available a follow-up report will be submitted. Reported to the fda on (b)(4) 2013.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1049092-2013-00061 |
| MDR Report Key | 3381059 |
| Report Source | 04,05,07 |
| Date Received | 2013-09-30 |
| Date of Report | 2013-09-03 |
| Date of Event | 2013-08-20 |
| Date Mfgr Received | 2013-09-03 |
| Date Added to Maude | 2013-10-03 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARY SZARO, ASSOC. DIRECTOR |
| Manufacturer Street | 200 HEADQUARTERS PARK DRIVE |
| 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 | 2013-09-30 |
| Model Number | 413177 |
| Catalog Number | 413177 |
| 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 | 1. Required No Informationntervention | 2013-09-30 |