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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS
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MALEM MEDICAL LTD. MALEM BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Model Number ULTIMATE PRO BEDWETTING ALARM
Device Problems Leak/Splash (1354); Overheating of Device (1437)
Patient Problems Bruise/Contusion (1754); Burn, Thermal (2530)
Event Date 10/06/2019
Event Type  Injury  
Event Description
Complaint is related to malem bedwetting alarm.Son was sleeping with alarm and it was the first time alarm was used.He was sleeping fine and he possibly wet and urinated.The sensor caught urine and the alarm beeped.He did not wake up to it.I heard the alarm after 20 mins and when i went in, he was crying and pulling on his shirt trying to remove the alarm.It was so hot and there was all that battery leak on his shirt.I tried to remove the alarm too but it was hot and could not hold it.I somehow took his arms out of the shirt and pulled it off.My son was bruised from the alarm and he is so traumatized.He has partial burns on his neck and check where the hot alarm touched him.The dr said it's not serious, but worth reporting.Seems dangerous.Fda safety report id# (b)(4).
 
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Brand Name
MALEM BEDWETTING ALARM
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD.
MDR Report Key9179641
MDR Text Key162310525
Report NumberMW5090341
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 10/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberULTIMATE PRO BEDWETTING ALARM
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Other;
Patient Age5 YR
Patient Weight21
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