MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM; ALARM, CONDITIONED RESPONSE ENURESIS

Model Number M04

Device Problems Vibration (1674); Output Problem (3005); Temperature Problem (3022)

Patient Problem No Patient Involvement (2645)

Event Date 03/05/2019

Event Type  Injury  

Event Description

Our alarm is not working correctly and warming up when batteries are in the alarm.The issue gets worse with sensor inserted.It has intermittent vibrations and you can actually feel it heat up in your hands.I was simply testing the product when it started malfunctioning and became erratic and dangerous to use.Fortunately my son was not using it or it might have injured him.

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8401685
• MDR Text Key: 138219600
• Report Number: MW5084729
• Device Sequence Number: 0
• Product Code: KPN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M04
• Device Catalogue Number: ULTIMATE ALARM
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 7 YR