MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,08 report with the FDA on 2015-05-28 for UNOMETER SAFETI PLUS-W/LUER-LOCK & LUER-SLIP 158100410190 manufactured by Unomedical Ltd..
[5897402]
The complainant reports when the open/close lever is in the closed position urine flows from the measurement chamber to the collection bag making it "impossible to obtain urine measurement. "
Patient Sequence No: 1, Text Type: D, B5
[13412411]
Based on the available information, this event is deemed a reportable malfunction. No further information was available at the time of the report. There were no reports of the patient being harmed as a result of this malfunction. Additional patient and event details have been requested. Should additional information become available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[39221247]
A quality complaint investigation was performed. Samples were not received. A detailed batch record review was performed. No non-conformance reports were initiated. A root cause investigation for the issue "urine is not collected in chamber" was performed. The true root cause cannot be identified based on the information 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 additional patient/ event details have been provided to date. Should additional information become available a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[54900455]
Add'l info providing the initial reporter of the complaint was received on june 16, 2015. This info was not captured on mdr 3007966929-2015-00046. F/u (1) submitted on july 2, 2015. No additional patient/event details have been provided to date. Should additional information become available, a follow-up report will be submitted. Reported to the fda on july 06, 2015.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007966929-2015-00046 |
| MDR Report Key | 4804444 |
| Report Source | 01,06,08 |
| Date Received | 2015-05-28 |
| Date of Report | 2015-05-12 |
| Date of Event | 2015-04-20 |
| Date Mfgr Received | 2015-05-12 |
| Device Manufacturer Date | 2014-11-01 |
| 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 |
| Manufacturer Phone | 9083779293 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNOMETER SAFETI PLUS-W/LUER-LOCK & LUER-SLIP |
| Generic Name | URINOMETER, MECHANICAL |
| Product Code | EXR |
| Date Received | 2015-05-28 |
| Model Number | 158100410190 |
| Lot Number | 180454 |
| Device Expiration Date | 2019-10-01 |
| 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 | 2015-05-28 |