MAUDE Adverse Event Report: MEDLINE MEDLINE URINAL

Model Number DYND80235S

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

Patient Problems Injury (2348); Skin Tears (2516)

Event Date 10/03/2016

Event Type  Injury  

Event Description

Patient was using urinal as intended, small skin tear to penis.Patient reported the issue and wasn't serious injured, antiseptics applied and skin follow ups showed no lasting injury.Dates of use: (b)(6) 2016.Diagnosis or reason for use: patient urinal.

• Brand Name: MEDLINE URINAL
• Type of Device: MEDLINE URINAL
• Manufacturer (Section D): MEDLINE; mundelein IL 60060
• MDR Report Key: 6003013
• MDR Text Key: 56909644
• Report Number: MW5065224
• Device Sequence Number: 1
• Product Code: FNP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYND80235S
• Device Catalogue Number: DYND80235S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 56 YR