MAUDE Adverse Event Report: MALEM MEDICAL MALEM BEDWETTING ALARM

Model Number M04

Device Problems Melted (1385); Overheating of Device (1437); Chemical Spillage (2894)

Patient Problem Caustic/Chemical Burns (2549)

Event Date 02/20/2018

Event Type  Injury  

Event Description

Last night, my son's bedwetting alarm burnt him.All we did was put batteries into the alarm and connect it on my son.An hour later, we went to his room and noticed that the alarm had black liquid coming out.The black liquid was from an overheated battery and the alarm was hot.The plastic that is the body of the alarm had partially melted and fused to his shirt.The black hot liquid had spread on his clothing and spread all over his body.He was asleep and unaware.The alarm was removed and we had to take him to the emergency room (er) for treatment where he was administered first aid for the burns.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: MALEM BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 7295758
• MDR Text Key: 101010642
• Report Number: MW5075483
• 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: 02/21/2018

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?: No
• 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: 02/23/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 8 YR