MAUDE Adverse Event Report: MALEM MALEM ALARM; BEDWETTING ALARM

Model Number MO48TEC

Device Problems Leak/Splash (1354); Electrical Shorting (2926); Temperature Problem (3022)

Patient Problem Burn, Thermal (2530)

Event Date 04/01/2018

Event Type  Injury  

Event Description

On the third night my son was using the malem alarm, something happened with the same.At night when he was sleeping, the alarm got very hot like something inside the alarm short circuited and caused it to heat up like a hot metal rod.The alarm case was also extremely hot and since it was in contact with my son's body, it burnt him.Additionally, the batteries leaked out of the alarm unit on to his skin and spread out on his body.He has suffered from skin burns from battery leak of the alarm.

• Brand Name: MALEM ALARM
• Type of Device: BEDWETTING ALARM
• Manufacturer (Section D): MALEM
• MDR Report Key: 7402173
• MDR Text Key: 104659134
• Report Number: MW5076339
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• 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: 04/04/2018

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: MO48TEC
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/05/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 8 YR