MAUDE Adverse Event Report: MEDEGEN MEDICAL PRODUCTS URINAL MALE DELUXE TRANSLUCENT

Lot Number 12951521

Device Problems Material Frayed (1262); Product Quality Problem (1506); Device Operates Differently Than Expected (2913)

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

Event Date 12/01/2016

Event Type  malfunction  

Event Description

Urinals have rough edges and many ridges on the inside causing a bladder stone to get stuck in the ridge and having to cut the urinal to retrieve the stone.

• Brand Name: URINAL MALE DELUXE TRANSLUCENT
• Type of Device: URINAL
• Manufacturer (Section D): MEDEGEN MEDICAL PRODUCTS; 209 medegen dr.; gallaway TN 38036
• MDR Report Key: 6236588
• MDR Text Key: 64290056
• Report Number: 6236588
• 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: 12/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 12951521
• Other Device ID Number: H140D-01
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/09/2016
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 12/09/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1