MAUDE Adverse Event Report: MALEM MALEM; BEDWETTING ALARM

Model Number M04

Device Problems Leak/Splash (1354); Overheating of Device (1437); Electrical Shorting (2926)

Patient Problem Burn, Thermal (2530)

Event Date 12/19/2017

Event Type  Injury  

Event Description

The malem bedwetting alarm overheated and the batteries shorted out.The batteries leaked onto my son's body at night and i had to remove the same from him to prevent harm.This is a dangerous product.

• Brand Name: MALEM
• Type of Device: BEDWETTING ALARM
• Manufacturer (Section D): MALEM
• MDR Report Key: 7145483
• MDR Text Key: 95803712
• Report Number: MW5074202
• 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: Other
• Type of Report: Initial
• Report Date: 12/22/2017

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 YR