MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-12-05 for SUR-FIT NATURA 2 PC POST OP UROSTOMY POUCH 416948 manufactured by Convatec, Inc..
[15126642]
The wound ostomy care nurse reported that the tape collar on the wafer will not stick within 1-2 days of wear when used on post operative urostomy patients. The tape collar lifts and migrates creating the wafer to leak. The collar lifts from either the top or close to the midline incision.
Patient Sequence No: 1, Text Type: D, B5
[15431101]
Based on the available info, this event is deemed to be a reportable malfunction. No add'l pt/event details have been provided to date. Should add'l info become available, a f/u report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1049092-2014-00601 |
| MDR Report Key | 4324821 |
| Report Source | 05 |
| Date Received | 2014-12-05 |
| Date of Report | 2014-11-05 |
| Date Mfgr Received | 2014-11-05 |
| Device Manufacturer Date | 2014-07-01 |
| Date Added to Maude | 2014-12-17 |
| 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. DIRECTO |
| 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 | SUR-FIT NATURA 2 PC POST OP UROSTOMY POUCH |
| Generic Name | BAG, DRAINAGE, WITH ADHESIVE, OSTOMY |
| Product Code | FON |
| Date Received | 2014-12-05 |
| Model Number | 416948 |
| Lot Number | 4G02585 |
| Device Expiration Date | 2019-07-28 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2014-12-05 |