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

Model Number M048TEC

Device Problems Leak/Splash (1354); Overheating of Device (1437); Device Operates Differently Than Expected (2913)

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

Event Date 04/09/2018

Event Type  Injury  

Event Description

My son was using the bedwetting alarm tonight for the first time and it has malfunctioned.We were using it normally and all we did was insert batteries and connect the urine sensing part as per the user manual.However, my son complained that the alarm was getting hot after 15 minutes and i also felt it when i touched the alarm.I removed it and set it aside only to watch it heat up and short circuit the batteries.The alarm leaked battery acid after 40 minutes and got very hot.So hot that it was not possible to hold it.This is not possible to place near my son's neck.

• Brand Name: MALEM ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM
• MDR Report Key: 7463859
• MDR Text Key: 106719966
• Report Number: MW5076727
• 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: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M048TEC
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR
• Patient Weight: 19