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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD MALEM BED-WETTING ALARM
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MALEM MEDICAL LTD MALEM BED-WETTING ALARM Back to Search Results
Device Problems Product Quality Problem (1506); Inappropriate/Inadequate Shock/Stimulation (1574); Temperature Problem (3022)
Patient Problems Burn, Thermal (2530); Electric Shock (2554)
Event Date 03/09/2017
Event Type  Injury  
Event Description
I bought a malem bedwetting alarm from the bedwetting store website some time back but never go to using it till 3 weeks ago.I use it for my mother who just had surgery.The alarm alerts us when she has wet herself at night.Last night, mom complained of minor shocks from the alarm when she wet, indeed, the malem was giving small shocks.We are able to feel it on our fingertips.Feels like a tens machine we use.Also, the malem bed wetting alarm is getting very hot at night during use.Last night after mom complained, i wanted to test it further and inserted fresh (b)(6) brand batteries.The alarm was very hot.My finger tip got burnt (nothing serious), but could have been very bad if it were connected to my shirt like i do on mom's shirt.I will ought to be using this alarm ever again.It has bad quality.It is shocking and heating up constantly.
 
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Brand Name
MALEM BED-WETTING ALARM
Type of Device
MALEM BED-WETTING ALARM
Manufacturer (Section D)
MALEM MEDICAL LTD
MDR Report Key6399400
MDR Text Key69796201
Report NumberMW5068419
Device Sequence Number1
Product Code KPN
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 03/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/10/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age74 YR
Patient Weight77
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