MAUDE Adverse Event Report: MALEM MEDICAL MALEM ENURESIS ALARM

Model Number M04S

Device Problems Break (1069); Leak/Splash (1354); Melted (1385); Overheating of Device (1437); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/21/2017

Event Type  Injury  

Event Description

All i did was insert batteries in the alarm for my daughter and set it on the desk while we had dinner.When i got back 45 minutes later, batteries had leaked from the alarm on to the desk and damaged the desk.The plastic had also partially melted from the battery leak heat.To think of what would have happened if my son were to wear it at night! i can't even imagine how dangerous this would be.I am happy that we did not use it.The results would be devastating.

• Brand Name: MALEM ENURESIS ALARM
• Type of Device: MALEM ENURESIS ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 6986650
• MDR Text Key: 90688468
• Report Number: MW5073019
• 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: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M04S
• 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: 4 YR