MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2015-02-26 for UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER 158100510190 manufactured by Unomedical Ltd..
[5472802]
It was reported that the pt had an urinometer placed while undergoing surgery. Initially, the pt had 'very low' diuresis. Two bottles of albumin 20% and five milligrams of furosemidum were administered to the pt with no result. The hosp staff then inspected the urinometer and found the insert to the chamber was loose and had stopped the flow of urine. No further info was provided.
Patient Sequence No: 1, Text Type: D, B5
[13000410]
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 and event details have been requested. Should additional info become available, a follow-up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007966929-2015-00030 |
| MDR Report Key | 4563777 |
| Report Source | 01,08 |
| Date Received | 2015-02-26 |
| Date of Report | 2015-01-30 |
| Date of Event | 2015-01-26 |
| Date Mfgr Received | 2015-01-30 |
| Device Manufacturer Date | 2014-04-01 |
| Date Added to Maude | 2015-03-31 |
| 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, 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 | 3 |
| Brand Name | UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER |
| Product Code | EXR |
| Date Received | 2015-02-26 |
| Model Number | 158100510190 |
| Lot Number | 491798 |
| Device Expiration Date | 2019-03-01 |
| 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 | 50 FANIPOL ZAVODSKAYA STREET DZERZHINSK DISTRICT MINSK REGION, MINSKA 222750 BO 222750 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-02-26 |