MAUDE Adverse Event Report: LSL HEALTHCARE INC MALE URINAL

Model Number 8601-2

Device Problem Fail-Safe Design Failure (1222)

Patient Problems Abrasion (1689); Hemorrhage/Bleeding (1888)

Event Date 03/22/2016

Event Type  Injury  

Event Description

An inpatient was using urinal in bathroom to urinate and scraped the head of his penis with the sharp edge of urinal.This resulted in an abrasion which bled.Pressure was applied to abrasion and bleeding stopped after about 3 minutes.Patient was on anticoagulant medication.

• Brand Name: MALE URINAL
• Type of Device: MALE URINAL
• Manufacturer (Section D): LSL HEALTHCARE INC; 5535 n. wolcott ave.; chicago IL 60640
• MDR Report Key: 5541599
• MDR Text Key: 41758466
• Report Number: MW5061418
• 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: 03/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 8601-2
• Device Catalogue Number: 8601-2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention