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

Model Number M04S - MAGENTA

Device Problems Defective Alarm (1014); Temperature Problem (3022)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/12/2018

Event Type  Injury  

Event Description

My son was sleeping with his enuresis alarm like he always does.But this night, the alarm has developed a defect and has gotten very hot.He complained to me 15-20 mins after he put it on and on checking.It was a defect.This alarm is getting very hot and i can't see myself placing it on him.After removing the alarm, i replaced the batteries and the alarm is again getting hot.When i say hot, i mean very hot.You can't touch it, it's that hot.For our safety, the batteries have been removed.

• Brand Name: MALEM ULTIMATE BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 7973369
• MDR Text Key: 124081750
• Report Number: MW5080583
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• 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: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04S - MAGENTA
• 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: 12 YR
• Patient Weight: 38