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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL, LTD. MALEM ULTIMATE SELECTABLE BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS
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MALEM MEDICAL, LTD. MALEM ULTIMATE SELECTABLE BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Catalog Number M05
Device Problems Burst Container or Vessel (1074); Battery Problem (2885); Electrical Shorting (2926); Material Twisted/Bent (2981)
Patient Problems Erythema (1840); Burn, Thermal (2530)
Event Date 02/19/2019
Event Type  Injury  
Event Description
I am reporting an adverse event in response to a bedwetting alarm which my son using at night on february 19.He was asleep at night with the alarm connected and when he woke up in the morning, the alarm had somehow electrically shorted out.It was not working when he woke up and there was battery residue on his clothes.The alarm door which holds batteries had bent from what appears to be heart that the alarm made.When he came back from school.I noticed red blisters and patches on his skin bear his neck.This only got worse over the next few days.Finally, we took him to the doctor who said that the red patches were a result of the alarm bursting at night when he was asleep.Fortunately he was wearing a sweater so it didn't cause much harm.
 
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Brand Name
MALEM ULTIMATE SELECTABLE BEDWETTING ALARM
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL, LTD.
MDR Report Key8381829
MDR Text Key137679178
Report NumberMW5084525
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 02/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue NumberM05
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age6 YR
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