MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08,distributor,foreign, report with the FDA on 2015-05-20 for UNOMETER SAFETI PLUS, 150CM 1,5L,RH 158100710190 manufactured by Unomedical Ltd..
[5853477]
It was reported urine did not flow out from bladder. It was further reported that the device was removed and replaced with another device fro a different lot.
Patient Sequence No: 1, Text Type: D, B5
[13302865]
Based on the available info, this event is deemed to be a reportable malfunction. Should additional info become available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[39248587]
A quality complaint investigation was performed. Samples were not received. A detailed batch record review was performed. No non-conformance reports related to the complaint issue was initiated. The root cause investigation for the issue "stop flow between pt and chamber" was performed. The true root cause cannot be identified based on the info received. No corrective action is required at the moment. A previous investigation is applicable to this complaint investigation. This previous investigation is closed. Therefore this complaint will be closed without further action. No add'l pt/event details have been provided to date. Should add'l info become available, a f/u report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007966929-2015-00045 |
| MDR Report Key | 4788184 |
| Report Source | 01,05,08,DISTRIBUTOR,FOREIGN, |
| Date Received | 2015-05-20 |
| Date of Report | 2015-05-04 |
| Date of Event | 2015-04-30 |
| Date Mfgr Received | 2015-05-04 |
| Device Manufacturer Date | 2014-09-01 |
| Date Added to Maude | 2015-06-19 |
| 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, INT.ASSOC.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 | UNOMETER SAFETI PLUS, 150CM 1,5L,RH |
| Generic Name | URINOMETER, MECHANICAL |
| Product Code | EXR |
| Date Received | 2015-05-20 |
| Model Number | 158100710190 |
| Lot Number | 167641 |
| Device Expiration Date | 2019-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNOMEDICAL LTD. |
| Manufacturer Address | ZAVODSKAYA STREET 50 FANIPOL DZERZHINSK DISTRICT MINSK REGION, MINSKAYA VOBLASTS 222750 BO 222750 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-20 |