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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD MALEM ULTIMATE BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS
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MALEM MEDICAL LTD MALEM ULTIMATE BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Model Number M04S - MAGENTA
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem Electric Shock (2554)
Event Date 05/15/2019
Event Type  Injury  
Event Description
My son is (b)(6) and he is on the taller side.He used the malem alarm, but the cord is short.So he placed the alarm on his pant.He was sleeping and wet the bed.Urine somehow got into the alarm and gave him a big shock at his genitals when he was asleep.He screamed out and had to pull the alarm out, but it was stuck.He was getting a shock for nearly a min before he could remove the alarm and throw it away.This is scary considering how it gave him a shock.I am in disbelief that this happened in the first place.He was fast asleep and this is just dangerous and very unsafe.The alarm has not been used since.Now, when i test it, it gives me a shock.Fda safety report id# (b)(4).
 
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Brand Name
MALEM ULTIMATE BEDWETTING ALARM
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD
MDR Report Key8632095
MDR Text Key145973552
Report NumberMW5086814
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
Type of Report Initial
Report Date 05/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberM04S - MAGENTA
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/21/2019
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age12 YR
Patient Weight39
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