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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL AND BEDWETTING STORE MALEM BEDWETTING ALARM; ENURESIS ALARM
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MALEM MEDICAL AND BEDWETTING STORE MALEM BEDWETTING ALARM; ENURESIS ALARM Back to Search Results
Lot Number NONE
Device Problems Burst Container or Vessel (1074); Overheating of Device (1437)
Patient Problem Burn(s) (1757)
Event Date 08/21/2017
Event Type  Injury  
Event Description
Our son used to wet the bed and we visited the (b)(6) store where it says the malem alarm can cure bedwetting.On the very first night of using the alarm my son screamed and i ran to his room.I noticed that the alarm had overheated and burnt him on his chest and neck.I threw the alarm on the floor and it actually exploded and burst into pieces.I was lucky to have thrown it on time otherwise it could have exploded on him.We then rushed him to the bathroom and applied cold water followed by ice on his burns.Then applied burn medication.We have shown him to the doctor and he has recovered significantly.I have seen several other complaints about the product online, then why has the fda not taken any action against this company and its products.I request that the fda look into this matter asap.
 
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Brand Name
MALEM BEDWETTING ALARM
Type of Device
ENURESIS ALARM
Manufacturer (Section D)
MALEM MEDICAL AND BEDWETTING STORE
MDR Report Key6826889
MDR Text Key83875487
Report NumberMW5071817
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 08/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Lot NumberNONE
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/29/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Treatment
OTC MEDS: CHILDREN'S MULTI-VITAMINS. ; RX MEDS: NONE.
Patient Outcome(s) Required Intervention;
Patient Age6 YR
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