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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MALEM BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS
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MALEM MALEM BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Device Problem Overheating of Device (1437)
Patient Problem Burn(s) (1757)
Event Type  Injury  
Event Description
Is the fda in our country sleeping or they are not interested in what is happening to children by using unsafe and junk products? my (b)(6) son is now terrified after using the malem bedwetting alarm that i bought for him to help him stop wetting the bed at night.This training has caused more harm than washing a load of dirty clothes.The malem alarm got so hot in the night that it has burnt a part of his body to the extent wherein i had to rush him to the hospital to get treated.Till date we have to do the dressing everyday.It has caused him so much pain that i am feeling terrified to even think why i had to buy such a useless alarm.Children¿s products should be passed through the fda so that no life-threatening products or even toys should be sold.I am a very upset mother wanting to take serious action about this bedwetting alarm.(b)(6).
 
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Brand Name
MALEM BEDWETTING ALARM
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM
MDR Report Key6739697
MDR Text Key81037524
Report NumberMW5071176
Device Sequence Number1
Product Code KPN
Combination Product (y/n)N
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 07/23/2017
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? No
Device Operator No Information
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/23/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age7 YR
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