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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL MALEM BEDWETTING ALARM; ENURESIS ALARM
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MALEM MEDICAL MALEM BEDWETTING ALARM; ENURESIS ALARM Back to Search Results
Model Number MO4S2EC
Device Problems Bent (1059); Leak/Splash (1354); Temperature Problem (3022)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/27/2018
Event Type  Injury  
Event Description
This is not a safe medical device for children, 4 times i put in new batteries and each time the device got warm.I contacted the seller whose website i purchased it from - (b)(6) but i did not get a response.Thinking that this is probably normal, let my daughter wear it to bed.She is so small, that she is unable to remove the product in case something happens.After i put it on her, she came to the living room crying and i noticed that the alarm had spilled out black liquid into her clothes.I immediately removed the alarm and found that it was not warm, but hot, very hot.The casing had become so hot that it was bent.My daughter had her thick sweater between her body and the device or else.It would surely have burnt her.This is not a safe alarm for children who use it.
 
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Brand Name
MALEM BEDWETTING ALARM
Type of Device
ENURESIS ALARM
Manufacturer (Section D)
MALEM MEDICAL
lowdham, nottingham NG14 7EJ
UK  NG14 7EJ
MDR Report Key7313104
MDR Text Key101575011
Report NumberMW5075641
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 Other Health Care Professional
Type of Report Initial
Report Date 02/28/2018
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 Health Professional
Device Model NumberMO4S2EC
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/28/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/01/2018
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age4 YR
Patient Weight18
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