MAUDE Adverse Event Report: MEDEGEN MEDICAL PRODUCTS, LLC MEDEGEN MEDICAL PRODUCTS URINAL

Model Number H140-01

Device Problem Sharp Edges (4013)

Patient Problem Laceration(s) (1946)

Event Date 03/23/2019

Event Type  malfunction  

Event Description

Patient utilized urinal.Following use the patient was noted to have blood around penis and in patients brief.It was noted by nursing staff that blood was also around run of urinal.Urinal was also noted to have rough edges which likely contributed to the laceration to patient.The patient did not need to be treated due to the small site and small amount of associated bleeding.

• Brand Name: MEDEGEN MEDICAL PRODUCTS URINAL
• Type of Device: URINAL
• Manufacturer (Section D): MEDEGEN MEDICAL PRODUCTS, LLC; 209 medegen drive; gallaway TN 38036
• MDR Report Key: 8935515
• MDR Text Key: 155670524
• Report Number: 8935515
• 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: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: H140-01
• Device Catalogue Number: H140-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/04/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29930 DA