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 2013-09-18 for SUR-FIT NATURA 2 PC DURAHESIVE CONVEX MOLDABLE 413181 manufactured by Convatec Inc..
[3717349]
End user called in to report she has developed a red, blotchy and occasionally weepy, non-itchy rash under the margins of the wafer's tape border. The rash began approx 1 month ago.
Patient Sequence No: 1, Text Type: D, B5
[11088012]
Based on the info, this is deemed a serious injury. From a clinical perspective, a causal relationship between the sur-fit nature 2 pc durahesive convex wafer and this event is deemed possible because product in use is temporally associated with the skin where the problem occurred. According to the end user, the rash extends beyond the tape from the 3 to 9 o'clock position. She cleans her skin with warm water and soap; and then applies the wafer. The end-user has been instructed on proper cleaning and care technique in the use of stomahesive powder and allkare protective barrier wipes. No add'l pt/event details have been provided to date. A return sample for eval is not expected. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1049092-2013-00021 |
| MDR Report Key | 3364938 |
| Report Source | 04,05,07 |
| Date Received | 2013-09-18 |
| Date of Report | 2013-08-21 |
| Date of Event | 2013-08-21 |
| Date Mfgr Received | 2013-08-21 |
| Date Added to Maude | 2013-09-25 |
| 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 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 MOLDABLE |
| Generic Name | PROTECTOR, OSTOMY |
| Product Code | EZS |
| Date Received | 2013-09-18 |
| Model Number | 413181 |
| Catalog Number | 413181 |
| Lot Number | 2K03169 |
| ID Number | 1161270 |
| 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 | 2013-09-18 |