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

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

Patient Problems Burn(s) (1757); Pain (1994)

Event Date 08/02/2017

Event Type  Injury  

Event Description

We bought the malem alarm from (b)(6) to potty train our son.On the very first night of using the alarm, it overheated and exploded.This has caused several burn marks on my son's neck.I have noticed hundreds of complaints online.If only the fda had pulled this product from the market sooner, my son would not have had to go through the pain and suffering.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED, RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 6830153
• MDR Text Key: 84090801
• Report Number: MW5071818
• 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: 08/26/2017

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: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening