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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS
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MALEM MEDICAL LTD BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Model Number M04
Device Problems Overheating of Device (1437); Temperature Problem (3022); Noise, Audible (3273)
Patient Problem No Code Available (3191)
Event Date 09/25/2018
Event Type  Injury  
Event Description
I have found a defect and problem with my daughter's malem enuresis alarm.This device, which is brand new is overheating when the moisture sensor is connected to it.The enuresis alarm starts making a strange sound and the backside becomes hot.It is not possible for my daughter to wear this alarm as the temperature will burn her.I have experienced with enuresis alarms, but this is not how they operate.This is clearly a mfg defect or a critical design flaw which can burn skin on contact within a few minutes.The enuresis alarm is new.
 
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Brand Name
BEDWETTING ALARM
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD
17737 new hamshire ave
ste 100
ashton MD 20861
MDR Report Key7929781
MDR Text Key122644506
Report NumberMW5080289
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 09/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberM04
Device Catalogue NumberULTIMATE SELECTABLE ALARM
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 Age8 YR
Patient Weight22
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