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

Model Number M SERIES

Device Problems Device Alarm System (1012); Overheating of Device (1437); Vibration (1674)

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

Event Date 04/30/2019

Event Type  malfunction  

Event Description

I am trying to use the malem alarm for the first time.I just received it but the alarm is not working correctly.On connecting it on my daughter, the alarm begins to vibrate gently and starts to become hot.The heat is not pronounced initially, but as time passes by, the alarm starts to get hotter and hotter.This is not how the device is supposed to operate.My daughter is (b)(6) and i am afraid that when she sleeps, this alarm can cause her injury.I let the alarm sit on the side and after about 35 mins, it was so hot that it could easily burn skin.I have tried to replace batteries, but the same thing happens over and over, indicating that the issue is not in the batteries, but in the device itself.Sound, lights and vibration in one alarm.Fda safety report id# (b)(4).

• Brand Name: MALEM ULTIMATE BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8573619
• MDR Text Key: 144010761
• Report Number: MW5086332
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M SERIES
• Device Catalogue Number: 044
• Device Lot Number: GOLD COLOUR
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 5 YR
• Patient Weight: 19