MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07,08 report with the FDA on 2014-02-07 for SUR-FIT NATURA 2 PC POST OP UROSTOMY POUCH KIT 416938 manufactured by Convatec Inc.
[4569084]
A distributor stated she received a report from an employee in the hosp operating room dept that stated there was a foreign object seen in a sterile package, which was not opened. It was further reported the foreign object "is red and looks like it could be a piece of a fingernail with red nail polish. "
Patient Sequence No: 1, Text Type: D, B5
[12086761]
Based on the available info, this event is deemed a reportable malfunction. The device was not used on a pt. No add'l pt/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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9618003-2014-00018 |
| MDR Report Key | 3865288 |
| Report Source | 05,06,07,08 |
| Date Received | 2014-02-07 |
| Date of Report | 2014-01-13 |
| Date of Event | 2014-01-13 |
| Date Mfgr Received | 2014-01-13 |
| Device Manufacturer Date | 2013-04-01 |
| Date Added to Maude | 2014-06-25 |
| 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, ASSOC. DIR. |
| Manufacturer Street | 200 HEADQUARTERS PARK DR |
| 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 POST OP UROSTOMY POUCH KIT |
| Generic Name | BAG, DRAINAGE, WITH ADHESIVE, OSTOMY |
| Product Code | FON |
| Date Received | 2014-02-07 |
| Model Number | 416938 |
| Catalog Number | 416938 |
| Lot Number | 3D00056 |
| Device Expiration Date | 2015-04-01 |
| 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 | CARRETERA SANCHEZ, KM. 18.2 PARQUE INDUSTRIAL ITABO, S.A. SAN CRISTOBAL, HAINA 3 DR 3 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-07 |