MAUDE Adverse Event Report: MALEM MEDICAL MALEM BEDWETTING ALARM; BED WETTING ALARM

Model Number M04S

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354); Melted (1385); Overheating of Device (1437)

Patient Problems Burn, Thermal (2530); Chemical Exposure (2570)

Event Date 01/01/2018

Event Type  Injury  

Event Description

Bed wetting alarm exploded under normal use and burnt my son on his neck.The heat made the plastic back to melt and the batteries also leaked on his clothing.He has blisters from the battery acid leak on his skin.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: BED WETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 7168465
• MDR Text Key: 96595793
• Report Number: MW5074405
• 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: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: M04S
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 6 YR