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

Model Number M04SB

Device Problems Temperature Problem (3022); Noise, Audible (3273)

Patient Problem Discomfort (2330)

Event Date 12/19/2018

Event Type  malfunction  

Event Description

My daughter's bedwetting alarm is heating up and not acting as it should.When i insert batteries, the alarm works fine, but when i insert the sensor, the alarm makes a ticking sound and starts getting hot, it's getting unusually hot on the backside, so hot that it's not possible to hold it, let alone, wear it at night.Something is not right with this device and certainly not one that can be worn in sleep.Defective and dangerous to use.

• Brand Name: MALEM
• Type of Device: ALARM,CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8189666
• MDR Text Key: 131342685
• Report Number: MW5082402
• 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: 12/19/2018

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: Lay User/Patient
• Device Model Number: M04SB
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 7 YR