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

Model Number PRO ALARM

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Date 10/13/2019

Event Type  malfunction  

Event Description

Alarm has been barely used for 1 night and it's already malfunctioning.My daughter is complaining that she got a big shock when she wet and it woke her up.Seemed impossible at first but when i tested it myself with some water, i noticed that i too got a shock on my hands.This is highly unsafe and cannot be used by anyone.The batteries are dead now.I am too worried to change and replace the batteries.(b)(4).

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL, LTD.
• MDR Report Key: 9202604
• MDR Text Key: 162852951
• Report Number: MW5090430
• 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: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: PRO ALARM
• 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): Other
• Patient Age: 5 YR