MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. SUPREME CLEAR URINAL WITH CLEAR COVER

Model Number DYND80235S

Device Problem Scratched Material (3020)

Patient Problems Hemorrhage/Bleeding (1888); Injury (2348)

Event Date 05/23/2014

Event Type  No Answer Provided  

Event Description

Patient sustained a minor cut from a urinal while in use.It is thought that the plastic on the urinal was too sharp and cut the patient's penis while trying to use the urinal.The nurse applied pressure to stop the bleeding and no additional treatment was required.
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manufacturer response for supreme urinal/ clear w/cover, medline (per site reporter).
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the sales rep thank me for telling him.

• Brand Name: SUPREME CLEAR URINAL WITH CLEAR COVER
• Type of Device: URINAL
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; 1 medline place; mundelein IL 60060
• MDR Report Key: 3893501
• MDR Text Key: 4674993
• Report Number: 3893501
• Device Sequence Number: 1
• Product Code: FNP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 06/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: *
• Device Operator: Patient
• Device Model Number: DYND80235S
• Device Catalogue Number: DYND80235S
• Device Lot Number: 315104421 0271
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/10/2014
• Event Location: Hospital
• Date Report to Manufacturer: 06/25/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1