MAUDE Adverse Event Report: MEDEGEN MEDICAL PRODUCTS MEDEGEN MEDICAL PRODUCT; URINAL

Model Number V-12

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 08/27/2018

Event Type  malfunction  

Event Description

(b)(6) medical product - urinal with handle #v-12.Three pts have reported injury to the genital within (b)(6) health corporation.

• Brand Name: MEDEGEN MEDICAL PRODUCT
• Type of Device: URINAL
• Manufacturer (Section D): MEDEGEN MEDICAL PRODUCTS; gallaway TN
• MDR Report Key: 7854882
• MDR Text Key: 119669620
• Report Number: MW5079652
• Device Sequence Number: 2
• Product Code: FNP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V-12
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1