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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 BEDWETTING ALARM
Device Problems Leak/Splash (1354); Overheating of Device (1437); Electrical Shorting (2926)
Patient Problem Burn, Thermal (2530)
Event Date 11/23/2018
Event Type  Injury  
Event Description
We have received a complaint that a (b)(6) girl was injured during sleep while using an enuresis alarm.The alarm was prescribed by the pharmacist and purchased by parents.The cause of injury is malfunction of the alarm during normal use.There appears nothing wrong with the way the device was used, but the cause of injury is attributed to the alarm malfunctioning and overheating.Device shorted out causing excess heat and battery leak on child¿s body.The child was diagnosed in our clinic and has been instructed to discontinue treatment with the alarm.The alarm has been returned back to our clinic and is available for evaluation.Parents wish not to have their personal details revealed.
 
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Brand Name
MALEM
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD
MDR Report Key8141931
MDR Text Key129824577
Report NumberMW5081912
Device Sequence Number1
Product Code KPN
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 12/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberULTIMATE BEDWETTING ALARM
Device Catalogue NumberM04S
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 Weight23
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