MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2014-10-23 for EAKIN FISTULA AND WOULD PCHES 839262 manufactured by Convatec Limited.
[4979557]
It was reported the end user observed a red rash extending beyond and below the mass of the pouch after using the product approximately two months. There are small red bumps along the outer edge and the rash is moist and itchy.
Patient Sequence No: 1, Text Type: D, B5
[12449217]
Based on the available info, this event is deemed to be a serious injury. End user's home health nurse switched her pouching product to a solid stomahesive wafer and pouch and has used the stomahesive powder to help dry the skin. Discussed possible candidiasis. She will call her doctor about an anti-fungal powder. Also, discussed how to patch test for sensitivity to other products being used. End user reports accessories in use include tincture of benzoin, skin prep by (b)(4), eakin seal and stomahesive powder. No add'l pt/event details has been provided to date. No sample is expected to be returned. Should add'l info become available, a f/u report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1000317571-2014-00101 |
| MDR Report Key | 4203244 |
| Report Source | 04,07 |
| Date Received | 2014-10-23 |
| Date of Report | 2014-10-20 |
| Date of Event | 2014-10-14 |
| Date Mfgr Received | 2014-10-20 |
| Device Manufacturer Date | 2014-05-01 |
| Date Added to Maude | 2014-10-28 |
| 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 | MATTHEW WALENCIAK, ASSOC. DIR. |
| Manufacturer Street | 211 AMERICAN AVE |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 9083779293 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EAKIN FISTULA AND WOULD PCHES |
| Generic Name | BAG, DRAINAGE WITH ADHESIVE, OSTOMY |
| Product Code | FON |
| Date Received | 2014-10-23 |
| Model Number | 839262 |
| Catalog Number | 839262 |
| Lot Number | 7820 |
| 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 LIMITED |
| Manufacturer Address | FIRST AVENUE DEESIDE INDUSTRIAL PARK DEESIDE, FLINTSHIRE CH52NU UK CH5 2NU |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-23 |