MAUDE Adverse Event Report: MALEM MALEM

Model Number M04

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2017

Event Type  Injury  

Event Description

I am a parent from (b)(6).I bought a brand new malem alarm on a trip to usa and gave it to my son to use to stop his enuresis.The bedwetting alarm is defective straight out of the box.As soon as batteries are put in the system, the alarm starts to get hot, very hot.My son was so scared to use it and we told him that it would get a little hot as we had heat on for the winter as well.But unfortunately, the complete alarm system went haywire and got very very hot.My boy had to pull it off and we saw battery leak on his nightdress.The alarm was hot like a metal rod.This could be very dangerous if it was not removed on time and could have caused permanent damage.

• Brand Name: MALEM
• Type of Device: MALEM
• Manufacturer (Section D): MALEM
• MDR Report Key: 7057374
• MDR Text Key: 92925430
• Report Number: MW5073540
• 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: 11/21/2017

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?: No
• Device Operator: No Information
• Device Model Number: M04
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/24/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 YR
• Patient Weight: 35