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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD. ULTIMATE BEDWETTING ALARM GOLD 8 TONE; ALARM, CONDITIONED RESPONSE ENURESIS
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MALEM MEDICAL LTD. ULTIMATE BEDWETTING ALARM GOLD 8 TONE; ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Device Problem Defective Component (2292)
Patient Problem Burn, Thermal (2530)
Event Date 12/03/2019
Event Type  Injury  
Event Description
Daughter was using the malem bedwetting alarm for the first time on night of december 3.Alarm was purchased from (b)(6) site which is the seller of the alarm.Product arrived in what appeared to be original packing and not damaged.User instructions were complicated so we saw the online videos.The alarm is defective from start.It was clicking when the sensor was plugged in.With no sensor and batteries, it seemed ok, but with sensor, it clicked.Nevertheless, i placed it on my daughter and put her to bed.She was awoken by a stinging sensation and by the time she realized, the alarm burned her skin.We administered first aid and took her to pediatrician next morning.Alarm is non-functional now.It will not respond to batteries on sensor.It's defective and after burning skin, has stopped working.Burns on skin.Fda safety report id# (b)(4).
 
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Brand Name
ULTIMATE BEDWETTING ALARM GOLD 8 TONE
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD.
MDR Report Key9451584
MDR Text Key170457457
Report NumberMW5091578
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 12/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age7 YR
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