MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2015-10-01 for URINARY CATHETER 02017182 manufactured by Unomedical Ltd..
[41981239]
Based on the available information, this event is deemed a reportable malfunction. There were no reports of the patient being harmed as a result of this malfunction. Additional details have been requested. Should additional information become available, a follow-up report will be submitted. Reported to the fda on 01/05/2015.
Patient Sequence No: 1, Text Type: N, H10
[41981240]
It was reported the tip of the catheter was bent prior to removal from the product packaging. The catheter was not used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005778470-2015-00020 |
| MDR Report Key | 5115698 |
| Report Source | FOREIGN |
| Date Received | 2015-10-01 |
| Date of Report | 2014-12-12 |
| Date Mfgr Received | 2014-12-12 |
| Date Added to Maude | 2015-10-01 |
| 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 | 3 |
| Event Location | 3 |
| 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 | 0 |
| Brand Name | URINARY CATHETER |
| Generic Name | CONNECTOR, CATHETER |
| Product Code | GCD |
| Date Received | 2015-10-01 |
| Model Number | 02017182 |
| Lot Number | 163604 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNOMEDICAL LTD. |
| Manufacturer Address | ZAVODSKAYA ST. 50 FANIPOL DZERZHINSK DISTRICT MINSKAYA VOBLASTS, MINSK REGION 222750 BO 222750 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-01 |