MAUDE Adverse Event Report: MALEM MEDICAL LTD MALEM ULTIMATE BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE, ENURESIS

Model Number M042

Device Problems Overheating of Device (1437); Vibration (1674)

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

Event Date 04/25/2019

Event Type  Injury  

Event Description

After having little to no success with potty pager and ddavp, my wife and i purchased the malem bedwetting alarm or our (b)(6) year old son who is constantly wetting the bed.The potty pager and the malem are operationally similar and not different.The use is also similar, just connecting a sensor outside the underwear and powering up the alarm.This alarm is however not working properly.It is vibrating when the batteries and sensor is plugged in and on top of that, the alarm is getting unusually hot when it is powered up.Takes about 30 minutes to go from room temperature to about 180 degrees fahrenheit.I thought this is a battery problem, but no matter how many times i change the batteries, the alarm did the same thing.This is too hot for a child to be using at night.I am afraid that it will cause burns and damage rather than do its intended purpose.It is not safe to use.Fda safety report # (b)(4).

• Brand Name: MALEM ULTIMATE BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE, ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8573803
• MDR Text Key: 143954559
• Report Number: MW5086335
• 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: 04/29/2019

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: Health Professional
• Device Model Number: M042
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/01/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR