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

Model Number M05RB

Device Problem Leak/Splash (1354)

Patient Problems Burn, Thermal (2530); Chemical Exposure (2570)

Event Date 07/08/2018

Event Type  Injury  

Event Description

A rather unexpected incident took place with my daughter.She was sleeping and using the malem alarm when we noticed that there was gray matter on her clothing.We looked closely and noticed that the alarm batteries were leaking.I removed the alarm but it was very hot, so hot that it did burn my fingertips.I am not sure how my daughter was sleeping with such a hot device.It is because there was a thick layer of clothing between her skin and the alarm.Fortunately we were able to remove batteries, and the damaged device is still with us and we will return to the seller.Horrible and dangerous device for children.

• Brand Name: MALEM ULTIMATE RECORDABLE BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 7685932
• MDR Text Key: 113921866
• Report Number: MW5078367
• 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: 07/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M05RB
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 9 YR
• Patient Weight: 29