MAUDE Adverse Event Report: UNOMEDICAL LTD. UNOMETER 500 ¿ URINEMETERS; DEVICE, URINE FLOW RATE MEASURING

Model Number 158101310190

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/25/2014

Event Type  malfunction  

Event Description

It was reported that the device was in use for 9 days.It was reported that on the report day, during the handling of the studied device by a nurse, the draining lever of the internal chamber detached from the device, became disarmed, and the closed system became damaged.The issue occurred at the urethra (collector system connected to the urethral).The damaged product was removed and a different unit was used.

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.The device was used on a patient, but there was no report of harm to the patient.In addition, it is reported that the evaluating institution issued a negative result for the evaluation of the device stating that the product's durability "cannot be proved." no additional information has been provided to date.Should additional information become available, a follow-up report will be submitted.Reported to the fda on (b)(4) 2014.

• Brand Name: UNOMETER 500 ¿ URINEMETERS
• Type of Device: DEVICE, URINE FLOW RATE MEASURING
• Manufacturer (Section D): UNOMEDICAL LTD.; zavodskaya street 50; fanipol dzerzhinsk district, minsk region; minskaya voblasts 22275 0; BO 222750
• Manufacturer Contact: matthew walenciak, int. ass. dir ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4188322
• MDR Text Key: 5097617
• Report Number: 3007966929-2014-00079
• Device Sequence Number: 1
• Product Code: FFG
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2018
• Device Model Number: 158101310190
• Device Catalogue Number: 158101310190
• Device Lot Number: 653951
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2014
• Initial Date FDA Received: 10/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Weight: 76