MAUDE Adverse Event Report: MALEM MEDICAL MALEM BEDWETTING ALARM; ENURESIS ALARM

Model Number M05

Device Problems Fire (1245); Melted (1385); Overheating of Device (1437); Material Rupture (1546)

Patient Problems Burn(s) (1757); Erythema (1840)

Event Date 12/02/2016

Event Type  Injury  

Event Description

My son was using a bedwetting alarm.It exploded at night and burnt his neck.If it was not for his t-shirt, he could have been in the hospital with a hole in his neck.The product was overheated and caught fire.At night, i put the sensor on my son's pajama and the alarm on his t-shirt near the neck.This is the first time i was using this product.I set it up as per the instructions, installed batteries and let my son in the room.Within an hour, i heard a loud scream and my son was crying loudly.I rushed to him and noticed that the blue malem bedwetting alarm had partially melted and my son's neck was burned red.The alarm has exploded and burnt a hole in his t-shirt.I immediately removed the alarm and threw it on the side.I still have it in my possession.I purchased the malem bedwetting alarm from (b)(6).I rushed my son to the er and they took care of him.I am worried that if i had not checked on my son on time, he would have permanent damage.This is a dangerous product sold to helpless children.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 6145296
• MDR Text Key: 61446007
• Report Number: MW5066531
• 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: 12/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M05
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/04/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 5 YR