MAUDE Adverse Event Report: MALEM MALEM BEDWETTING ALARM

Model Number BLUE

Device Problems Melted (1385); Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 06/16/2017

Event Type  Injury  

Event Description

This weekend my daughter was using the malem bed wetting alarm at night exactly the same way she had been doing it for the last 3 nights when the alarm malfunctioned and burnt her chest.The blue battery enclosure door had melted because of the heat and hurt her very badly.I had to use neosporin on her chest, but i am not able to understand how or why this is even possible.What can cause a battery powered product to burn a hole in clothing and burn skin.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: BEDWETTING ALARM
• Manufacturer (Section D): MALEM
• MDR Report Key: 6662948
• MDR Text Key: 78365616
• Report Number: MW5070577
• Device Sequence Number: 1
• 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: 06/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: BLUE
• Device Catalogue Number: ULTIMATE BEDWETTING 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