MAUDE Adverse Event Report: MEDEGEN MEDICAL PRODUCTS, LLC TRANSLUCENT URINAL, HANG HANDLE & COVER

Catalog Number H140-01

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/07/2016

Event Type  malfunction  

Event Description

The urinal was leaking urine from a hole, at the base of the urinal.Three patients reported leaking urinals over the course of two days.I also talked to the distribution center in the hospital who supply the urinals to the departments and they said they seem thinner than what they used to be.Some of the urinals seem thinner in the corner where the wholes were.Manufacturer response for urinal, (brand not provided) (per site reporter): they are sending me ship material.

• Brand Name: TRANSLUCENT URINAL, HANG HANDLE & COVER
• Type of Device: URINAL
• Manufacturer (Section D): MEDEGEN MEDICAL PRODUCTS, LLC; 209 medegen dr.; gallaway TN 38036
• MDR Report Key: 6215528
• MDR Text Key: 63636726
• Report Number: 6215528
• Device Sequence Number: 1
• Product Code: FNP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: H140-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/12/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 12/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO; NO OTHER THERAPIES
• Patient Age: 57 YR