MAUDE Adverse Event Report: MALEM MEDICAL MALEM ULTIMATE BEDWETTING ALARM

Device Problems Melted (1385); Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 10/19/2017

Event Type  Injury  

Event Description

The malem bedwetting alarm is the worst product that i have ever purchased.I thought he would overcome bedwetting, instead the alarm overheated and the back of the alarm melted and burnt my child.My child had to be rushed to the hospital.I have seen multiple similar complaints about this product online.Then why has no action been taken as yet against this company.Are you waiting for a child to get critically hurt or get handicapped for life? my child is hurt and i don't know how i am going to pay the hospital bills.I need to know: why did the alarm get hot? why was this product not inspected? when will the fda take action? to help you take action, i bought the malem ultimate bedwetting alarm from (b)(6).

• Brand Name: MALEM ULTIMATE BEDWETTING ALARM
• Type of Device: MALEM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 6983153
• MDR Text Key: 90519068
• Report Number: MW5072973
• 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: 10/25/2017

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/27/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 5 YR