MAUDE Adverse Event Report: MALEM MALEM BEDWETTING ALARM

Device Problems Melted (1385); Smoking (1585); Noise, Audible (3273)

Patient Problem No Information (3190)

Event Date 06/25/2017

Event Type  Injury  

Event Description

Last night when my daughter used the bedwetting alarm, she had an adverse action to the product.It was set up right and she went to bed, but sometime at night, the alarm started making a clicking sound.I was sleeping beside my daughter and heard the clicking sound.There were fumes coming from the alarm.I quickly removed it and in the process noticed that the back casing had heated and there was gray matter that was starting to come out from the back of the alarm.The alarm was placed on the desk and it was extremely hot.A few minutes later, the back battery door melted.Disappointed with the alarm.Very dangerous for children.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: MALEM BEDWETTING ALARM
• Manufacturer (Section D): MALEM
• MDR Report Key: 6672768
• MDR Text Key: 78675668
• Report Number: MW5070661
• Device Sequence Number: 1
• Product Code: KPN
• 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: 06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR