MAUDE Adverse Event Report: MALEM MALEM BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS

Device Problem Overheating of Device (1437)

Patient Problems Burn(s) (1757); Pain (1994)

Event Type  Injury  

Event Description

I have a horrific complaint regarding a horrible product called the malem bedwetting alarm that is used by small children to stop peeing in the bed at night.I also have a concern for other children who are using this product.I am a working mom of three young daughters and my (b)(6) twins are bedwetters.To shed my load of washing i was looking for some solution that can help stop their peeing in the bed so i came across this device and bought two malem bedwetting alarms.But the third day of using it proved how cheap and dangerous this device really is.To my horror, i heard one of my twins scream in the middle of the night and i ran to her room and noticed a burn mark on her neck, she had managed to pull the alarm from her night dress and throw it on the floor, but not until she had suffered severe burns.She was screaming in pain and was shivering.When i tried to pick up the alarm from the floor it was burning hot.I am sure that if i had not removed the batteries from the alarm at that moment, it would have burst in no time at all.I rushed her to the emergency room, why are these kind of dangerous devices in the market? why such a device being sold in the us market? i would expect the fda to take serious action against this product and the company who is selling it for the safety of children.(b)(6) store (b)(6).

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM
• MDR Report Key: 6739696
• MDR Text Key: 81037517
• Report Number: MW5071175
• 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: 07/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention