MAUDE Adverse Event Report: MALEM BEDWETTING ALARM

Device Problem Melted (1385)

Patient Problem Burn(s) (1757)

Event Date 05/10/2017

Event Type  Injury  

Event Description

I purchased a malem bedwetting alarm to stop bedwetting in my (b)(6) year old son.The alarm was set up tonight as we did the first night, yesterday and my son went to bed.Just a few hours ago, the bedwetting alarm malfunctioned and the battery door at the back of the alarm melted and the melting plastic burnt my son on his neck.This is a dangerous product.I took my son to the hospital as the burns were serious.The alarm could be very harmful and would have caused more damage had i not intervened.Did the problem stop after the person reduced the dose or stopped taking or using the product: yes.

• Brand Name: BEDWETTING ALARM
• Type of Device: BEDWETTING ALARM
• Manufacturer (Section D): MALEM
• MDR Report Key: 6566294
• MDR Text Key: 75257629
• Report Number: MW5069729
• 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: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 5 YR