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

Model Number M04

Device Problems Leak/Splash (1354); Overheating of Device (1437); Device Operates Differently Than Expected (2913)

Patient Problems Rash (2033); Partial thickness (Second Degree) Burn (2694)

Event Type  malfunction  

Event Description

The alarm was recommended by a family friend for my (b)(6) daughter.It does not work properly and is not safe.The alarm is dangerous.Within minutes of placing batteries, the alarm starts heating up and gets very hot.My daughter was in bed with this new device and she came running to us 30 minutes later.The alarm device was very hot and the battery leaked on my daughter's clothes.She has suffered skin rash and blisters as well as minor burns from the device.Not safe for a small child.

• Brand Name: BEDWETTING ALARM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 7596045
• MDR Text Key: 111019048
• Report Number: MW5077797
• 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: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M04
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 6 YR
• Patient Weight: 22