MAUDE Adverse Event Report: MALEM MALEM

Model Number M04SC

Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)

Patient Problem Caustic/Chemical Burns (2549)

Event Date 03/14/2018

Event Type  malfunction  

Event Description

Daughter's enuresis alarm malfunctioned and batteries leaked out causing skin burns.The alarm unit was only 2 days old and burned my daughter at night when it was in use.Returned to company where it was purchased from and daughter was treated in the clinic.

• Brand Name: MALEM
• Type of Device: MALEM
• Manufacturer (Section D): MALEM
• MDR Report Key: 7352119
• MDR Text Key: 102995488
• Report Number: MW5075935
• 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: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04SC
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 3 YR
• Patient Weight: 15