MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2013-09-24 for SUR-FIT NATURA 2 PC DURAHESIVE CONVEX WAFER 413181 manufactured by Convatec, A Division Of E.r. Squibb & Sons L.l.c..
[21882869]
End user reported within the last two weeks rash has developed under the tape border. He described this rash as raw. This rash does not extend beyond the tape or under the mass. It is located at the 4 o'clock position on the peristomal skin and measures between 25 mm and 38 mm. He had a similar rash in 2009 and did seek medical attention at that time. He is currently using that prescription metrazol powder to treat.
Patient Sequence No: 1, Text Type: D, B5
[21895586]
Based on the available info, this event is deemed a serious injury. End user was instructed to check the expiration date on the metrazol powder and contact his primary physician. He was also instructed on crusting techniques, using stomahesive powder or antifungal powder according to his doctor's instructions, and allkare protective barrier wipes. From a clinical perspective, a causal relationship between the sur-fit natura 2 pc durahesive moldable wafer and this event is deemed possible because product use is temporarily associated with the skin where the problem occurred. No add'l patient/event details have been provided to date. Should add'l info become available a follow-up report will be submitted. A return sample for eval is not expected. Reported to fda on (b)(4) 2013. (b)(4). Note: the actual date of event is unk, so the date used was the date convatec became aware.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1049092-2013-00044 |
| MDR Report Key | 3373519 |
| Report Source | 04,07 |
| Date Received | 2013-09-24 |
| Date of Report | 2013-08-26 |
| Date of Event | 2013-08-26 |
| Date Mfgr Received | 2013-08-26 |
| Device Manufacturer Date | 2012-01-24 |
| 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 DRIVE |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9089042450 |
| Manufacturer G1 | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C. |
| Manufacturer Street | 211 AMERICAN AVE. |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27409 |
| 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 | OSTOMY POUCH AND ACCESSORIES |
| Product Code | EZS |
| Date Received | 2013-09-24 |
| Model Number | 413181 |
| Catalog Number | 413181 |
| Lot Number | 2A02034 |
| Device Expiration Date | 2017-01-22 |
| 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, A DIVISION OF E.R. SQUIBB & SONS L.L.C. |
| Manufacturer Address | 211 AMERICAN AVE. GREENSBORO NC 27409 US 27409 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-24 |