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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM ULTIMATE BED-WETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS
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MALEM MEDICAL LTD. MALEM ULTIMATE BED-WETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Model Number M04SC - CAMOUFLAGE
Device Problem Temperature Problem (3022)
Patient Problems Pain (1994); Burn, Thermal (2530)
Event Date 01/31/2019
Event Type  Injury  
Event Description
Last night, our son suffered a scare when his malem bed-wetting alarm malfunctioned and caused him pain.Purchased in new condition and delivered intact, the alarm was operated as per the directions in the user manual.Son went to sleep, 30 minutes later, the alarm started ringing loudly.Checked son, but there was no bed-wetting.So i reached to turn off the alarm and immediately noticed that it was hot.I also saw that it was touching my sons chest.Immediately removed the alarm.About an hour later, the alarm cooled down but would not work anymore.My son complained of pain on his chest from using the alarm.We put neosporin to alleviate his pain.That did not work very well.He had small blisters now.We are taking him to the pediatrician for treatment.The malem bed-wetting alarm would not be used again.
 
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Brand Name
MALEM ULTIMATE BED-WETTING ALARM
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD.
MDR Report Key8306537
MDR Text Key135724102
Report NumberMW5083704
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 02/01/2019
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 No Information
Device Model NumberM04SC - CAMOUFLAGE
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/04/2019
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age5 YR
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