MAUDE Adverse Event Report: MALEM MEDICAL MALEM; BEDWETTING ALARM

Model Number M04S

Device Problems Burst Container or Vessel (1074); Overheating of Device (1437); Chemical Spillage (2894)

Patient Problem Caustic/Chemical Burns (2549)

Event Date 02/07/2018

Event Type  Injury  

Event Description

My son was sleeping at night and the bedwetting alarm exploded.The alarm got very hot and leaked batteries on to my son's chest region causing burns.

• Brand Name: MALEM
• Type of Device: BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 7288770
• MDR Text Key: 100775524
• Report Number: MW5075396
• 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: 02/19/2018

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: M04S
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/21/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR