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

Device Problems Leak/Splash (1354); Temperature Problem (3022); Noise, Audible (3273)

Patient Problem No Information (3190)

Event Date 08/20/2017

Event Type  Injury  

Event Description

Just received the malem alarm from (b)(6) today.The alarm has malfunctioned the very first night.We set up the alarm and placed it by the table and started reading instructions of use.Within a few minutes, the alarm started making a strange click sound and a few minutes later, the batteries leaked out of the alarm as it was placed on the table.Very strange.The alarm was extremely hot just placed on the table.Very dangerous.I wonder what would have happened if my daughter had worn it.How can batteries leak and how can the alarm become so hot.This is to be placed near my daughter's neck.

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 6812700
• MDR Text Key: 83480683
• Report Number: MW5071746
• 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: 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• 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