MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06,07 report with the FDA on 2014-06-04 for SUR-FIT NATURA 2 PC - DISPOSABLE CONVEX INSERT 404009 manufactured by Convatec Inc.
[4674374]
It is reported that the end-user was hospitalized on (b)(6) 2014 for a duration of three (3) weeks and receiving intravenous antibiotics via pic line for a stomach infection related to repeated use of the same convex insert. The pt was instructed, by the infectious disease doctor, to use a new convex insert each time that the wafer is changed. The end-user was using "sur-fit natura disposable convex inserts" with "sur-fit natura durahesive skin barrier w/flange". The "sur-fit natura durahesive skin barrier w/flange" was changed every three (3) days, and end-user was reusing each convex insert for eighteen (18) days. The area was washed with soap and water prior to inserting a new wafer. It is also reported that end-user used a non-convatec brand adhesive remover then applied turbo cement, and also used eakin cohesive seals before applying wafer. The product was in use for eighteen days (18) before the issue occurred. Lastly, it is reported that end-user has been discharged to home now and is afebrile and states that he is doing good and "i feel better than i have ever felt".
Patient Sequence No: 1, Text Type: D, B5
[12020563]
Based on the available info, this event is deemed to be a serious injury. An alternate product sample has been sent, and the use of ostomy appliance belt was discussed with end-user. No add'l pt/event details have been provided to date. A return sample for eval is not expected. Should add'l info become available, a follow up report will be submitted. (b)(4) convatex will continue to track and monitor such complaints according to convatec inc's. Complaint handling and capa procedures.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1049092-2014-00168 |
| MDR Report Key | 3888033 |
| Report Source | 04,05,06,07 |
| Date Received | 2014-06-04 |
| Date of Report | 2014-05-09 |
| Date of Event | 2014-02-07 |
| Date Mfgr Received | 2014-05-09 |
| Date Added to Maude | 2014-06-24 |
| 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, INTERIM ASSOC |
| 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 - DISPOSABLE CONVEX INSERT |
| Generic Name | APPLIANCE, COLOSTOMY, DISPOSABLE |
| Product Code | EZS |
| Date Received | 2014-06-04 |
| Model Number | 404009 |
| Catalog Number | 404009 |
| Lot Number | UNK |
| 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. Hospitalization; 2. Required No Informationntervention | 2014-06-04 |