MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM BED-WETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS

Model Number M04

Device Problem Overheating of Device (1437)

Patient Problem No Code Available (3191)

Event Date 12/24/2018

Event Type  Injury  

Event Description

My son has used two of these malem alarms with no success.First malem alarm was model m04 and that was a problem where it would overheat when son was asleep.The heat was significant to wake him up and discontinue use.After two nights of failed use and overheating, we returned the product and upgraded to the m05 version.Same thing again; it's not the batteries because we have changed them.It's something in the product itself that is misbehaving and causing heat.You can feel it hot when you hold it in your hands.Sleeping with this alarm is not possible.

• Brand Name: MALEM BED-WETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8203223
• MDR Text Key: 131889660
• Report Number: MW5082674
• 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: 12/26/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/27/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR