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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD MALEM; ALARM, CONDITIONED RESPONSE
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MALEM MEDICAL LTD MALEM; ALARM, CONDITIONED RESPONSE Back to Search Results
Model Number ULTIMATE BEDWETTING ALARM
Device Problems Overheating of Device (1437); Temperature Problem (3022); Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/26/2019
Event Type  Injury  
Event Description
Within a matter of minutes of inserting the malem alarm and powering it up, the alarm makes a non-stop clicking noise and starts warming up.It is not usable as is because, of the large amount of heat that it is producing.Most devices may have some heat when batteries are operated but, this alarm is going from room temperature to warm to hot to very hot in a matter of 30 ¿ 45 minutes.I made the mistake of placing it on my daughter but, when she said its hot, i immediately removed it.We have used another alarm in the past but that did not get hot at all.This alarm is strange and not acting normally.
 
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Brand Name
MALEM
Type of Device
ALARM, CONDITIONED RESPONSE
Manufacturer (Section D)
MALEM MEDICAL LTD
MDR Report Key8382136
MDR Text Key137666896
Report NumberMW5084556
Device Sequence Number0
Product Code KPN
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 02/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberULTIMATE BEDWETTING ALARM
Device Catalogue NumberM05
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/28/2019
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
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