MAUDE Adverse Event Report: MEDEGEN MEDICAL PRODUCTS URINAL WTRANSCVR DELUX

Model Number H140D-01

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2023

Event Type  malfunction  

Event Description

There is a notebook ring size hole in the bottom of the urinal.Multiple devices in the supply room demonstrated the same hole.Any liquid placed in the urinal will leak out the bottom rendering it ineffective.

• Brand Name: URINAL WTRANSCVR DELUX
• Type of Device: URINAL
• Manufacturer (Section D): MEDEGEN MEDICAL PRODUCTS; 209 medegen dr.; gallaway TN 38036
• MDR Report Key: 17548643
• MDR Text Key: 321159868
• Report Number: 17548643
• Device Sequence Number: 1
• Product Code: FNP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: H140D-01
• Device Catalogue Number: H140D-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/03/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other