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

Model Number M04SB

Device Problems Vibration (1674); Material Twisted/Bent (2981); Temperature Problem (3022)

Patient Problems Bruise/Contusion (1754); Scarring (2061); Burn, Thermal (2530)

Event Date 12/18/2018

Event Type  Injury  

Event Description

We purchased a malem bed-wetting alarm online last week and it has not been working correctly since the first day.Every time i put in batteries, the alarm starts vibrating.It goes beyond.The vibration is light, but significant enough to heat up the device.Something is stuck inside the device that is causing it to heat up and vibrate like this.I wasn't sure that it would heat any further and let my son sleep with it, only to find out 30 minutes later it burnt his skin.The bed- wetting alarm plastic has bent from the heat and my son's neck has been scarred.We have treated him for minor burns and bruises at the nearby clinic.

• Brand Name: MALEM BED-WETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8199647
• MDR Text Key: 131701630
• Report Number: MW5082623
• 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: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: M04SB
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 8 YR
• Patient Weight: 19