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

Model Number M05

Device Problem Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 10/14/2018

Event Type  Injury  

Event Description

For no apparent reason at all, the enuresis alarm is getting hot.You put in the batteries and the sensor, and it's getting hot like boiling water.Something was seriously wrong with the device.My son was wearing it in his afternoon nap and complained if stinging.Had to remove batteries to prevent overheating and skin burn.Not safe.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 7973357
• MDR Text Key: 124080800
• Report Number: MW5080581
• 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: 10/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M05
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR
• Patient Weight: 15