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

Model Number M04

Device Problems Leak/Splash (1354); Overheating of Device (1437)

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

Event Date 11/01/2018

Event Type  Injury  

Event Description

We have 2 malem alarms in the house and one has stopped working correctly.The defective alarm is overheating.My son complained at night that he was experiencing a stinging sensation.I noticed that the alarm was hot and removed it.It only took a few mins after that for the alarm to get extremely hot, and then the batteries inside the alarm exploded and i saw gray matter coming out from the inside.I have stopped using both alarms and am very concerned.

• Brand Name: MALEM ULTIMATE BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8045966
• MDR Text Key: 126527587
• Report Number: MW5081104
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6 YR
• Patient Weight: 24