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

Model Number M04SC

Device Problems No Audible Alarm (1019); Leak/Splash (1354); Overheating of Device (1437); Material Deformation (2976)

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

Event Date 10/16/2018

Event Type  Injury  

Event Description

We are operating the malem alarm correctly, but it continues to have a mind of its own.The alarm is erratic and unpredictable.When turned on, it is fine and the buttons work.However, when the sensor is plugged into the alarm with the sensor lifted up, the alarm starts to make a small vibration which can barely be heard.Within a few mins, the alarm starts getting warm and hotter.About 30 mins later, it's hot to touch and 45 mins later, the batteries leak out and the back of the alarm where the batteries are placed deformed.Intense heat from this device.I am lucky that my daughter was not wearing it when this happened.

• Brand Name: MALEM ULTIMATE BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 7994973
• MDR Text Key: 124793083
• Report Number: MW5080733
• 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: 10/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M04SC
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Outcome(s): Required Intervention
• Patient Weight: 31