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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM MEDICAL BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE
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MALEM MEDICAL LTD. MALEM MEDICAL BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE Back to Search Results
Model Number BEDWETTING ALARM
Device Problems Leak/Splash (1354); Device Emits Odor (1425); Overheating of Device (1437)
Patient Problems Pain (1994); Scarring (2061); Partial thickness (Second Degree) Burn (2694)
Event Date 11/06/2019
Event Type  Injury  
Event Description
Alarm is erratic.Operated properly on the first night of use and second night, daughter has an accident but alarm did not detect any wetness.On the third night, alarm overheated and scarred daughter's skin on her neck.She was in pain and crying out when she woke up.Nothing changed, nothing was different from the first two nights.There was burning plastic smell in her room.The batteries leaked from the backside of the alarm too.In the morning, the scarred skin had a big blister on it.The alarm is unsafe and dangerous.It has been returned.Fda safety report id # (b)(4).
 
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Brand Name
MALEM MEDICAL BEDWETTING ALARM
Type of Device
ALARM, CONDITIONED RESPONSE
Manufacturer (Section D)
MALEM MEDICAL LTD.
MDR Report Key9315878
MDR Text Key166340435
Report NumberMW5091008
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 11/09/2019
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 Lay User/Patient
Device Model NumberBEDWETTING ALARM
Device Catalogue NumberULTIMATE PRO ALARM
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/12/2019
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age7 YR
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