MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM ALARMS TO STOP BEDWETTING IN CHILDREN; ALARM, CONDITIONED RESPONSE ENURESIS

Model Number M042

Device Problems Thermal Decomposition of Device (1071); Melted (1385); Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Date 05/13/2019

Event Type  malfunction  

Event Description

We didn't even use the bedwetting alarm as it is defective.I inserted batteries and connected the sensor.It seemed to work fine.Then i lay it on the bed.When i came back an hour later, there was black sticky on the bed.The bedsheet had a hole and so did the mattress.The alarm back had melted and fused to the mattress.The alarm exploded and did all that.This is a new alarm and my daughter who is (b)(6) was going to use it.Poor quality and dangerous.It burnt my bedsheet and mattress.It would have seriously hurt my daughter.Fda safety report id# (b)(4).

• Brand Name: MALEM ALARMS TO STOP BEDWETTING IN CHILDREN
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8615948
• MDR Text Key: 145476581
• Report Number: MW5086683
• 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: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M042
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 5 YR