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..
[5617536]
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
[13097065]
Based on the available info, this event is deemed a reportable malfunction. There were no reports of the pt being harmed as a result of this malfunction. Additional pt/event details have been requested. Should additional info become available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005778470-2015-00004 |
| MDR Report Key | 4641724 |
| 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, INT ASSO DIR |
| Manufacturer Street | 211 AMERICAN AVENUE |
| 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 |