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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM ALARM; ALARM, CONDITIONED RESPONSE ENURESIS
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MALEM MEDICAL LTD. MALEM ALARM; ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Model Number M04
Device Problems Device Emits Odor (1425); Overheating of Device (1437); Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/14/2018
Event Type  Injury  
Event Description
Purchased a bedwetting alarm from (b)(6).They recommended a malem alarm for my daughter who is (b)(6).We received the alarm and saw instructions online (videos) and in the user manual.However we put in batteries, this alarm making a rattling sound like something was stuck inside.Then a few mins later, it started getting warm on the bottom site and that is when i removed the batteries and used another new pair of batteries.Still same thing happened.At one point, about 30 mins later, the alarm was extremely hot and smelled bad like something inside the alarm was burning.At that point, we removed the batteries carefully or it would easily burn my hand.The alarm was returned back to the mfr/seller.
 
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Brand Name
MALEM ALARM
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD.
MDR Report Key7533484
MDR Text Key108952041
Report NumberMW5077341
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 05/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberM04
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/21/2018
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age8 YR
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