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

Model Number ULTIMATE SELECTABLE ALARM

Device Problems Overheating of Device (1437); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 03/05/2019

Event Type  malfunction  

Event Description

Our doctor told us to purchase a bedwetting alarm to help my son stop his wetting habit.After much research, we purchased malem.The idea is to wake up my son when he wets the bed with tactical alerts like vibration and beeping.However this alarm does neither of those things.All it does is it gets hot when the sensor is connected.When the batteries are placed inside, the alarm is ok, but when the sensor plugs in, you can feel it vibrate gently and the back and underside start getting hot.It takes a few minutes and its too hot to hold.This is not normal and heat is not the right way to wake up a bedwetter.

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8405660
• MDR Text Key: 138406133
• Report Number: MW5084782
• 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: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ULTIMATE SELECTABLE ALARM
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/08/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6 YR