MAUDE Adverse Event Report: MALEM MEDICAL MALEM MEDICAL ALARM

Model Number M04

Device Problems Burst Container or Vessel (1074); Melted (1385); Overheating of Device (1437)

Patient Problems Scarring (2061); Burn, Thermal (2530)

Event Date 05/11/2017

Event Type  Injury  

Event Description

We purchased a malem bedwetting alarm for my son from (b)(6).The alarm overheated and exploded the very first night of use.The battery compartment cover melted and burnt my son's neck.He had to be rushed to the hospital and the doctor recommended that we discontinue it and report to the fda.His burns are serious and they have caused permanent scarring on his neck.

• Brand Name: MALEM MEDICAL ALARM
• Type of Device: MALEM MEDICAL ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 6568556
• MDR Text Key: 75319016
• Report Number: MW5069778
• 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: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/12/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening