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

Device Problems Fire (1245); Leak/Splash (1354); Melted (1385)

Patient Problem Burn(s) (1757)

Event Date 01/21/2017

Event Type  Injury  

Event Description

Received a malem alarm and used it for 2 weeks.Things seemed to be going ok till one night, the batteries leaked from the back and the plastic part of the alarm melted.Alarm caught fire.I was just sitting besides my daughter and she was laying in bed when this happened.She said "mommy, its burning," and started crying.I am still surprised how a battery powered product can cause so much damage.She has suffered small burns on her chest area.We went to the doctor's office and were told to report this to the fda.

• Brand Name: MALEM ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 6279049
• MDR Text Key: 65821716
• Report Number: MW5067467
• Device Sequence Number: 1
• Product Code: KPN
• 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: 01/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/24/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR
• Patient Weight: 21