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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL MALEM ENURESIS ALARM
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MALEM MEDICAL MALEM ENURESIS ALARM Back to Search Results
Model Number M04
Device Problems Leak/Splash (1354); Overheating of Device (1437); Chemical Spillage (2894); Electrical Shorting (2926)
Patient Problems Bruise/Contusion (1754); Erythema (1840); Rash (2033); Scarring (2061); Caustic/Chemical Burns (2549)
Event Date 02/10/2018
Event Type  Injury  
Event Description
I received the malem alarm 3 days ago.On inserting batteries, the alarm got hot, then cooled down, then hot and then again cooled down like a cycle.I took out the batteries and set it aside.Tried it again last night.The alarm seemed to be acting normally so i set it up on my daughter.Last night, your daughter's malem bedwetting alarm sporadically heated up when it was used for 3 hrs.The alarm was extremely hot and short circuited from the inside.The heat caused the batteries to leak and the battery leak has burnt my daughter.She has been bruised and scarred by the burns.The clinic is giving her first aid.Currently she has red patches and rash from the battery leak.The clinic has told us to report this to the fda.
 
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Brand Name
MALEM ENURESIS ALARM
Type of Device
ENURESIS ALARM
Manufacturer (Section D)
MALEM MEDICAL
UK 
MDR Report Key7269519
MDR Text Key100129382
Report NumberMW5075217
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 02/11/2018
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? No
Device Operator Lay User/Patient
Device Model NumberM04
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/13/2018
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age3 YR
Patient Weight14
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