MAUDE Adverse Event Report: MALEM MEDICAL UK MALEM ALARMS; ENURESIS ALARM

Model Number M04S

Device Problems Overheating of Device (1437); Noise, Audible (3273)

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

Event Date 03/18/2018

Event Type  Injury  

Event Description

Over the weekend, the malem alarm burnt and scarred my son.The alarm was purchased as a replacement to another alarm which had gotten wet and stopped working.This alarm is actually very dangerous and not working as expected.It gets very hot and keeps making a clicking sound.My son complained of a hot surface within an hour of use, so i stopped using it on him.The alarm was so hot at the time i removed it.Then i took out batteries and retried but the same thing kept happening.I stopped use after my son's chin was burnt by the alarm.

• Brand Name: MALEM ALARMS
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): MALEM MEDICAL UK; UK
• MDR Report Key: 7365071
• MDR Text Key: 103345825
• Report Number: MW5075985
• 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: 03/20/2018

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
• Device Model Number: M04S
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 4 YR