MAUDE Adverse Event Report: MALEM MEDICAL/BEDWETTING STORE MALEM BEDWETTING ALARM

Device Problems Melted (1385); Temperature Problem (3022)

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

Event Date 04/09/2016

Event Type  Injury  

Event Description

Malem bedwetting alarm, blue color (1 tone) was purchased by me for my(b)(6) son who is handicapped to stop wetting the bed at night.The alarm was purchased from the bedwetting store as they claim their alarm can cure bedwetting.On day 2, when using the alarm, the unit was as hot as a piece of coal and melted the battery door, this led to severe burns on my son's neck.My son had to go through excruciating pain and unnecessary doctor visits.I have noticed multiple complaints on the fda site.So what is the fda waiting for and why has no action been taken as yet?.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: MALEM BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL/BEDWETTING STORE
• MDR Report Key: 6551133
• MDR Text Key: 74720957
• Report Number: MW5069594
• Device Sequence Number: 1
• Product Code: KPN
• 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: 05/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 6 YR