MAUDE Adverse Event Report: MALEM UK MALEM ALARM; ALARM, CONDITIONED RESPONSE

Model Number M04

Device Problems Melted (1385); Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 01/15/2018

Event Type  Injury  

Event Description

Four days ago, my son woke up at night screaming and crying because his alarm burnt his neck.The alarm was brand new.I am not understanding how this can be happening.The alarm is only using two batteries, then how is it possible that this alarm can get so hot.I make my son wear it and it immediately started working and then in 1 hour, it gets so hot that it completely burns my son.I am very angry and scared from using this alarm now.The alarm is getting so hot that the plastic cover melted in the alarm.I bought brand new alarm for my son.This is very dangerous.

• Brand Name: MALEM ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE
• Manufacturer (Section D): MALEM UK
• MDR Report Key: 7211913
• MDR Text Key: 98058901
• Report Number: MW5074700
• 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: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 7 YR