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

Device Problem Protective Measures Problem (3015)

Patient Problem Electric Shock (2554)

Event Date 08/16/2019

Event Type  Injury  

Event Description

Our alarm is giving small electrical shocks on the privates when it is detecting urine.This is causing us to be wary of using the device.The electrical shock can also be felt on the palm of my hand when water is placed.Not sure if this is unsafe, but this is not the correct mode of operation of the device.Barely used for 1 day and it is a new product purchased from the mfr.Fda safety report id# (b)(4).

• Brand Name: MALEM PRO ULTIMATE ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8927203
• MDR Text Key: 155531952
• Report Number: MW5089278
• 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: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6 YR