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

Model Number M04

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354); Temperature Problem (3022)

Patient Problem Burn, Thermal (2530)

Event Date 03/19/2019

Event Type  Injury  

Event Description

The malem alarm has literally exploded at night when my son was sleeping.It got very hot when he was sleeping and the batteries leaked out at night.The alarm is new and i don't know what caused it.I set it up and used it as it was supposed to do.But it took 1 hour after my son went to sleep to explode and injure him.The alarm is hot and burnt his skin near his neck.I am very upset and scared to use any other alarm as well.

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED, RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8456833
• MDR Text Key: 140211075
• Report Number: MW5085214
• 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: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04
• 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
• Patient Age: 5 YR
• Patient Weight: 21