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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL MALEM BED WETTING ENURESIS ALARM FOR BOYS AND GIRLS
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MALEM MEDICAL MALEM BED WETTING ENURESIS ALARM FOR BOYS AND GIRLS Back to Search Results
Model Number BLUE ALARM
Device Problems Melted (1385); Inappropriate/Inadequate Shock/Stimulation (1574); Temperature Problem (3022)
Patient Problem Electric Shock (2554)
Event Date 02/01/2017
Event Type  Injury  
Event Description
Something very strange with the malem alarm.It would give my son mild shocks when he would wet the bed.He told us this after a few days of use.The problem got worse when he cut himself while playing soccer.That night when he wet, the alarm gave him a nasty shock which made him cry out in pain.The shock continued till we pulled out the batteries.A full 30 seconds.Also, noticed that the alarm had started heating up and the back case of the alarm was very hot.The batteries had melted in only 30 seconds.Dangerous product.We contacted (b)(6) from where we purchased the product they issued us a refund.Good riddance.
 
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Brand Name
MALEM BED WETTING ENURESIS ALARM FOR BOYS AND GIRLS
Type of Device
MALEM BED WETTING ENURESIS ALARM
Manufacturer (Section D)
MALEM MEDICAL
MDR Report Key6475211
MDR Text Key72347996
Report NumberMW5068978
Device Sequence Number1
Product Code KPN
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 04/06/2017
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 Lay User/Patient
Device Model NumberBLUE ALARM
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/06/2017
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 Age6 YR
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