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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD. ULTIMATE PRO BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS
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MALEM MEDICAL LTD. ULTIMATE PRO BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Device Problem Scratched Material (3020)
Patient Problems Hemorrhage/Bleeding (1888); Tissue Damage (2104)
Event Date 10/09/2019
Event Type  Injury  
Event Description
The malem alarm has 2 parts, the alarm portion and the clip sensor.The clip sensor was attached on my daughter's underwear and the alarm was on her shirt.The cable was underneath her shirt as explained in the user manual.However, at night when she slept, the clip sensor detached from her underwear and came lose.Then she likely moved in bed and the clip sensor cut her skin at night when she was sleep.She started bleeding and was hurt from the injury.She was crying when i reached her.I noticed blood and she was in pain.The sensor has sharp metal plates coming out from the sides as a result of poor design.That is as sharp as a needle and it caused the very sharp cut.If one runs their finger on the sensor, it will easily cut the finger.Sharp and very dangerous.Fda safety report id# (b)(4).
 
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Brand Name
ULTIMATE PRO BEDWETTING ALARM
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD.
MDR Report Key9224837
MDR Text Key163605315
Report NumberMW5090561
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 10/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age6 YR
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