MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2015-03-26 for URINARY CATHETER 02016559 manufactured by Unomedical S.r.o..
[16185693]
It was reported that upon receipt, the urinary catheter appeared to have been "folded. " during urethra introduction, the urinary catheter, 'folded precisely at the point of initial folding' when being inserted. No pt injuries were reported.
Patient Sequence No: 1, Text Type: D, B5
[16351071]
Based on the available info, this event is deemed to be a reportable malfunction. There was no reports of the pt being harmed as a result of this malfunction. Add'l pt/event details have been requested. Should add'l info become available, a f/u report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005778470-2015-00003 |
| MDR Report Key | 4641731 |
| Report Source | 01,08 |
| Date Received | 2015-03-26 |
| Date of Report | 2015-02-20 |
| Date Mfgr Received | 2015-02-20 |
| Date Added to Maude | 2015-05-08 |
| 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 VE |
| 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 | URINARY CATHETER |
| Generic Name | CONNECTOR, CATHETER |
| Product Code | GCD |
| Date Received | 2015-03-26 |
| Model Number | 02016559 |
| Lot Number | 172168 |
| 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 | UNOMEDICAL S.R.O. |
| Manufacturer Address | PRIEMYSELNY PARK 3 MICHALOVCE 07101 LO 07101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-26 |