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

Device Problems Leak/Splash (1354); Melted (1385); Overheating of Device (1437)

Patient Problems Burn(s) (1757); Swelling (2091)

Event Date 06/27/2017

Event Type  Injury  

Event Description

I have bought a bedwetting alarm for my son and he started using the alarm 3 nights ago.Every night, the alarm has become very hot and after 4-5 hours.I have to remove batteries and let it cool down.Then again resume after one hour.But tonight was very different.The alarm got so hot that the plastic housing has melted and my son has been burnt very badly on his neck and around the neck line.There are big red bumps and strange white liquid has spilled out from the alarm.The batteries have leaked out.My son has been taken to urgent care.

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM
• MDR Report Key: 6676465
• MDR Text Key: 78908713
• Report Number: MW5070685
• 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: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 6 YR