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

Model Number PRO ALARM

Device Problems Device Alarm System (1012); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 08/08/2019

Event Type  malfunction  

Event Description

My daughter has been complaining of electrical shocks in her sleep when she is using the alarm.She sweats in bed and the sensor is defecting sweat.However, the alarm is not making any sound or vibration.It is giving her shocks on genital area.This has been going on for 2 nights, so i have stopped using it and returned it back.The alarm is not damaged or used.This is a brand new product which is giving shocks.Fda safety report id# (b)(4).

• Brand Name: MALEM PRO
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8892957
• MDR Text Key: 154460632
• Report Number: MW5088999
• 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: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: PRO ALARM
• Device Catalogue Number: ULTIMATE VERSION
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6 YR