MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. URINAL

Catalog Number DYND80235S

Device Problem Scratched Material (3020)

Patient Problem Laceration(s) (1946)

Event Date 12/11/2013

Event Type  Injury  

Event Description

The patient suffered a cut to his penis from a sharp edge on the urinal.

Manufacturer Narrative

It was reported that while using the urinal, a male patient suffered a cut to his penis from a sharp edge on the rim.The cut was repaired with surgical adhesive without further incident.The size and extent of the laceration was not reported.The actual sample was not retained for evaluation and the lot number of the device is not known.

• Brand Name: URINAL
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; mundelein IL
• Manufacturer Contact: julie finley ; one medline place; mundelein, IL 60060 ; 8476434709
• MDR Report Key: 3600580
• MDR Text Key: 4190127
• Report Number: 1417592-2014-00002
• 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: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: DYND80235S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 12/11/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 81 YR