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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD. ULTIMATE ALARM ; ALARM, CONDITIONED RESPONSE ENURESIS
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MALEM MEDICAL LTD. ULTIMATE ALARM ; ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Model Number M04SB-ROYAL BLUE
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problems Tingling (2171); Electric Shock (2554)
Event Date 06/18/2019
Event Type  Injury  
Event Description
Son is a frequent bedwetter and was recommended the malem ultimate alarm by family friends.The alarm is dangerous and has scared us.Son is (b)(6) y/o and i set up the alarm when he went to sleep.Everything seemed fine till he actually wet the bed and the alarm buzzer started.I went to his room and he was crying.He said that his penis was getting shocks.I was confused and didn't understand.It took about 30 secs more before i removed the cable and that is when it stopped.This alarm is giving my son shocks.I tested the alarm on my hand and could feel a strong tingling on my fingers when i placed the sensor on my palm and under water.Needless to say, it's been returned and i have been worried, scared to use another shock therapy system.Fda safety report id# (b)(4).
 
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Brand Name
ULTIMATE ALARM
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD.
MDR Report Key8735276
MDR Text Key149478180
Report NumberMW5087617
Device Sequence Number1
Product Code KPN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 06/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberM04SB-ROYAL BLUE
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age4 YR
Patient Weight22
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