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

Model Number ULTIMATE ALARM

Device Problem Unintended Electrical Shock (4018)

Patient Problems Sweating (2444); Shock from Patient Lead(s) (3162)

Event Date 07/09/2019

Event Type  Injury  

Event Description

The pediatrician recommended that my son use a bedwetting alarm to treat his wetting problem.The alarm we found on the internet was malem and purchased it in new condition from the mfr's website.The alarm has been used for 3 nights and each night, my son did not wet the bed, but he has complained of getting shocks.He sweats a lot and this causes the alarm to vibrate (i have it on vibrate setting).It does vibrate and he gets shocks.He did not tell me the first three nights, but when i went to attach it on him, he was scared and refused to wear.He was awake all night, afraid that if he wets, he will get another shock.I put the alarm and sensor in a damp cloth and touched it as well and i can feel a tingling on my fingers.This is unsafe to operate on him.This is shock therapy, not what we expected.Fda safety report id# (b)(4).

• Brand Name: MALEM ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8793410
• MDR Text Key: 151293723
• Report Number: MW5088128
• 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: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE ALARM
• Device Lot Number: LIGHT BLUE COLOR
• 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; Required Intervention
• Patient Age: 4 YR