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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD. ULTIMATE PRO ALARM; ALARM, CONDITIONED RESPONSE ENURESIS
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MALEM MEDICAL LTD. ULTIMATE PRO ALARM; ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Model Number ULTIMATE PRO ALARM
Device Problems Device Emits Odor (1425); Overheating of Device (1437); Defective Component (2292); Noise, Audible (3273)
Patient Problem No Patient Involvement (2645)
Event Date 07/16/2019
Event Type  Injury  
Event Description
Our malem bedwetting alarm has a serious defect.Straight out of the box, the unit is acting strange and not the way the user manual explains.There is some loose part within the alarm part (blue box).When i shake the alarm, it is moving inside.Like someone forgot and left something inside.I can't see it through the plastic case.If i connect batteries, the alarm is making strange knocking sound.It is not possible to sleep with this sound, so i let the alarm sit for a few mins.Within 10 mins, there was burning smell from the alarm and it was hot when i touched it.I immediately removed the batteries and packed it and returned it to the company.Doesn't appear to be safe.Getting hot with batteries is abnormal.Fda safety report id # (b)(4).
 
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Brand Name
ULTIMATE PRO ALARM
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD.
MDR Report Key8837562
MDR Text Key152610349
Report NumberMW5088410
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 07/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberULTIMATE PRO ALARM
Was Device Available for Evaluation? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age5 YR
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