MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04,07 report with the FDA on 2013-09-23 for SUR-FIT NATURA 2 PC DURAHESIVE CONVEX WAFER 402204 manufactured by Convatec Inc.
[21947868]
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. According to the end-user, they have not experienced any issues with the handling of the product, and has had no changes within the specified time period. 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. See scanned page.
Patient Sequence No: 1, Text Type: N, H10
[21997046]
End-user reports that for 4 weeks, they have experienced itching and dry skin under the wafer's tape border.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1049092-2013-00036 |
| MDR Report Key | 3373017 |
| Report Source | 01,04,07 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | 402204 |
| Catalog Number | 402204 |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 |