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

Model Number BLUE SINGLE TONE ALARM

Device Problems Overheating of Device (1437); Vibration (1674); Device Unsafe to Use in Environment (2918)

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

Event Date 06/14/2018

Event Type  malfunction  

Event Description

While trying to place the malem alarm on my son, i realized that the alarm was very hot.All i did was put batteries in the device and it started vibrating.Something in the electronics was stuck in there that caused it to vibrate and generate heat.In 10 minutes the device was hot and the only thing i could do was remove the batteries to let it cool.The same thing happens when another set of batteries is placed.It's like the device has a short circuit that causes it to heat up.This device cannot be used on a child as it may be deadly at night.

• Brand Name: MALEM ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 7609487
• MDR Text Key: 111441331
• Report Number: MW5077889
• 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: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: BLUE SINGLE TONE ALARM
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 3 YR