MAUDE Adverse Event Report: MALEM UK MALEM BEDWETTING ALARM

Model Number M04

Device Problems Burst Container or Vessel (1074); Melted (1385); Overheating of Device (1437)

Patient Problem Caustic/Chemical Burns (2549)

Event Date 01/25/2018

Event Type  Injury  

Event Description

A product which was purchased to stop bedwetting in my son has exploded at night and burnt my son.The explosion happened rapidly and he did not get a chance to protect himself.The product which is a malem alarm got extremely hot to point where the battery door melted and the batteries leaked onto his body.The hot battery acid has burnt his neck and chin, and he has blisters now.We rushed him to the hospital where he was treated in the er.He has not recovered even after 1 week.I am very disappointed with this product.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: MALEM BEDWETTING ALARM
• Manufacturer (Section D): MALEM UK
• MDR Report Key: 7233661
• MDR Text Key: 98844155
• Report Number: MW5074989
• 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: 01/30/2018

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?: No
• Device Operator: No Information
• Device Model Number: M04
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 5 YR