MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM ULTIMATE BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE

Model Number M04

Device Problems Burst Container or Vessel (1074); Overheating of Device (1437); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 08/03/2018

Event Type  Injury  

Event Description

My son's malem bedwetting alarm has malfunctioned and in the process exploded.It was only operated once.Batteries were placed per directions and we wet it up on the bed.When we returned an hour later, there were fumes coming from the device.It was extremely hot like it was on fire, and the plastic had bent inwards where batteries are placed.I am lucky my son was not wearing it at the time this incident happened or it would have easily burnt him.

• Brand Name: MALEM ULTIMATE BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 7805129
• MDR Text Key: 117970080
• Report Number: MW5079271
• 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: 08/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 08/21/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR
• Patient Weight: 25