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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM; ALARM, CONDITIONED RESPONSE ENURESIS
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MALEM MEDICAL LTD. MALEM; ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Model Number ULTIMATE ALARM FOR BEDWETTING
Device Problems Leak/Splash (1354); Overheating of Device (1437)
Patient Problem Burn, Thermal (2530)
Event Date 08/14/2019
Event Type  Injury  
Event Description
Electrical failure in the enuresis alarm occurred within 30 mins of use.My son was asleep at the time and woke up to a strong, high temperature device pressing against his skin.The device was connected near his shoulder and at the time, he was sleeping on his stomach.The high temperature which is the result of device defect left a bright red spot on his shoulder.He was able to remove the alarm promptly and report to me.I set it aside, unable to remove the batteries from fear it might blow up.After a few more mins, it cooled down and the two batteries that are inside discharged, spilling battery acid on the device.My son is scared and we refuse to continue this treatment.Fda safety report id# (b)(4).
 
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Brand Name
MALEM
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD.
MDR Report Key8927131
MDR Text Key155503952
Report NumberMW5089271
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 08/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberULTIMATE ALARM FOR BEDWETTING
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age5 YR
Patient Weight24
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