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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
Device Problems Overheating of Device (1437); Defective Device (2588)
Patient Problems Injury (2348); Burn, Thermal (2530)
Event Date 06/01/2019
Event Type  Injury  
Event Description
The malem alarm is defective.This is the second alarm that is doing exactly the same thing.The first one was operating erratically when batteries were placed in.It would vibrate constantly and get hot within minutes.I contacted the manufacturer and they said it could be a manufacturing defect.I returned this alarm and they sent me a replacement alarm.They claim it is new, but it is doing the exact same thing.I felt it vibrate when i put in batteries and when i tried to remove the alarm, i hurt my fingers and burnt my palm.This is not a safe device.I have gone through two of these alarms and both are getting hot and defective.Fda safety report id # (b)(4).
 
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Brand Name
MALEM
Type of Device
BEDWETTING ALARM/ ALARM CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD.
MDR Report Key8674870
MDR Text Key147431726
Report NumberMW5087159
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 06/03/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received06/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberULTIMATE
Device Catalogue NumberM042
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) Other;
Patient Age6 YR
Patient Weight24
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