MAUDE Adverse Event Report: MALEM MEDICAL MALEM MEDICAL BEDWETTING ALARM

Model Number M04S2

Device Problems Melted (1385); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/23/2016

Event Type  Injury  

Event Description

Purchased a bed-wetting alarm for my (b)(6) daughter.Inserted batteries at night and set it up correctly as per instructions.My daughter was laying in bed and when i went in 10 minutes later, the alarm made a hissing sound and started to melt.Fortunately my daughter was wearing a thick sweater.The alarm back melted and burnt the front of the sweater.This is a dangerous product.No issue with batteries.Just a faulty inferior quality product.

• Brand Name: MALEM MEDICAL BEDWETTING ALARM
• Type of Device: BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 6215292
• MDR Text Key: 63736674
• Report Number: MW5066972
• 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: 12/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04S2
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR
• Patient Weight: 23