MAUDE Adverse Event Report: MALEM MEDICAL MALEM BEDWETTING ALARM

Model Number MO4S2

Device Problems Melted (1385); Overheating of Device (1437)

Patient Problems Pain (1994); Burn, Thermal (2530)

Event Date 12/13/2016

Event Type  Injury  

Event Description

I purchased a nocturnal enuresis alarm for my (b)(6) boy from the bedwetting store website - (b)(6).I purchased a malem bedwetting alarm from them you can see the product at (b)(6).I put in batteries and showed my son how to use it.I put the alarm and clip sensor on him and went to bed.At about 3:30 am in the morning, he screamed in pain and ran to me.The malem alarm was on fire.The plastic housing has started to melt and the unit was so hot that it hurt my son.I am frustrated and devastated from this.I took my son to the hospital emergency room and treated him for burns.This is a horrible product.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: MALEM BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 6180390
• MDR Text Key: 62548999
• Report Number: MW5066712
• Device Sequence Number: 1
• Product Code: KPN
• 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: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MO4S2
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/14/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 5 YR