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

Model Number M04S

Device Problems Overheating of Device (1437); Material Twisted/Bent (2981)

Patient Problem Burn, Thermal (2530)

Event Date 03/21/2019

Event Type  No Answer Provided  

Event Description

My (b)(6) was sleeping with his bed wetting alarm and the cord kept coming out of the alarm as he is tall.I decided to place the alarm on his waist instead of his shoulder and he slept.He wet the bed and the alarm went off, but the alarm short and overheat.This caused him to get burnt on his stomach where the alarm was placed.The back of the battery door has bent outward clearly from excess heat that came from the alarm.I helped son change and took him to the emergency room.He is mildly burnt from the alarm which has since been handled over to the emergency room.

• Brand Name: MALEM ULTIMATE BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 8471003
• MDR Text Key: 140754113
• Report Number: MW5085449
• 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: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: M04S
• Device Catalogue Number: MAGENTA
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 14 YR