MAUDE Adverse Event Report: UNOMEDICAL LTD. UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER; URINOMETER, MECHANICAL

Model Number 158101310190

Device Problem Detachment Of Device Component (1104)

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

Event Date 06/29/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "the top measuring chamber is faulty causing the whole hourly measuring chamber to be removed from the top chamber.".

• Brand Name: UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER
• Type of Device: URINOMETER, MECHANICAL
• Manufacturer (Section D): UNOMEDICAL LTD.; zavodskaya street; 50 fanipol dzerzhinsk district; minsk region, minskaya voblast 22275 0; BO 222750
• Manufacturer (Section G): CONVATEC INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: matthew walenciak ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 5048587
• MDR Text Key: 24776304
• Report Number: 3007966929-2015-00077
• Device Sequence Number: 1
• Product Code: EXR
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K896732
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Report Date: 07/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 158101310190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1