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

Model Number M05

Device Problem Temperature Problem (3022)

Patient Problem Discomfort (2330)

Event Type  malfunction  

Event Description

After just 2 nights of using the bedwetting alarm, we have noticed excessive heat from the back of the device making it unsafe for use under normal operation.The first night, the alarm worked fine, but tonight, the alarm is heating up and is too hot to hold in hand without burning skin.This doesn't appear to normal operation of a children's device.Have stopped using it.Changing batteries has not helped and the problem lies in the device itself.

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8142491
• MDR Text Key: 129908070
• Report Number: MW5081955
• 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: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M05
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 9 YR
• Patient Weight: 34