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

Model Number M04

Device Problems Overheating of Device (1437); Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/17/2019

Event Type  Injury  

Event Description

Out malem alarm is defective.The alarm is constantly vibrating when i put inside batteries and plug sensor.This is making the alarm become very hot and i can¿t hold it in my hands.The heat is too high for safe operation especially when my son will be sleeping.I used another alarm before, but this never happened.I am not certain why this is happening with the alarm.It is not wet or abused.But the heat is so much that i am worried it will explode.Can¿t be used for my son.

• Brand Name: MALEM ALARM
• Type of Device: ALARM, CODITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8362686
• MDR Text Key: 137155223
• Report Number: MW5084225
• 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: 02/18/2019

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: Lay User/Patient
• Device Model Number: M04
• Device Catalogue Number: ULTIMATE BEDWETTING ALARM
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/21/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR