MAUDE Adverse Event Report: MALEM MEDICAL BED WETTING ALARM

Model Number M04

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

Patient Problems Scarring (2061); Burn, Thermal (2530)

Event Date 10/07/2016

Event Type  Injury  

Event Description

I had recommended an enuresis alarm for my patient.The mother purchased the device for treatment of primary nocturnal enuresis at (b)(6).The mother followed all instructions for use and when batteries were inserted in the alarm to power on, the mother attached it to the subjects t-shirt and left for the night.At night, the alarm overheated and exploded causing severe burns to the child.The mother called me up immediately and discontinued the product.The child has burn marks on his neck and scarring which could have been more serious if not addressed appropriately.Diagnosis or reason for use: primary nocturnal enuresis.

• Brand Name: BED WETTING ALARM
• Type of Device: BED WETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL; nottingham, gb NG14 7EJ; UK NG14 7EJ
• MDR Report Key: 6022193
• MDR Text Key: 57168560
• Report Number: MW5065338
• Device Sequence Number: 1
• Product Code: KPN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M04
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 4 YR
• Patient Weight: 26