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

Model Number ULTIMATE ALARM

Device Problem Overheating of Device (1437)

Patient Problem Discomfort (2330)

Event Date 04/02/2019

Event Type  Injury  

Event Description

I have not even used the device on my son.Every time i am connecting batteries and sensor, the alarm is getting hot.I can't even hold it in my hands, its so hot.My son will surely get burnt if he wears it and sleeps.I have changed the batteries with (b)(4), but that is not helping.The batteries don't matter.In this case, it is the alarm portion that is getting unusually hot.Could be a malfunction or a problem with the device, but it is certainly not safe.Fda safety report id # : (b)(4).

• Brand Name: MALEM BETWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE, ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8503907
• MDR Text Key: 141782160
• Report Number: MW5085777
• 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: 04/08/2019

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: No Information
• Device Model Number: ULTIMATE ALARM
• Device Lot Number: RED COLOR
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/10/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 MO