Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM ULTIMATE BEDWETTING ALARM; ALARM, CONDITIONED RESPOSNE ENURESIS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MALEM MEDICAL LTD. MALEM ULTIMATE BEDWETTING ALARM; ALARM, CONDITIONED RESPOSNE ENURESIS Back to Search Results
Model Number M043
Device Problems Thermal Decomposition of Device (1071); Leak/Splash (1354); Temperature Problem (3022)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/01/2019
Event Type  Injury  
Event Description
After a night of what we believe was correct operation, the malem alarm malfunctioned last night.We were sleeping and heard the alarm go off.My daughter had wet the bed and alarm detected it.My daughter did not wake up and i went to wake her up.She was sleepy, so i removed the alarm and it continued to ring and vibrate.After my daughter used the restroom and changed her clothes, i picked up the alarm to place it back on her.But i immediately dropped it cause it was very hot.My daughter barely took 15 minutes to change but the alarm had some electrical issue and it was dangerously hot.I let it sit and after 20 more minutes, after which the batteries leaked out and the alarm stopped ringing, i thought it would catch fire.The shape of the alarm changed from the heat as well.Fda safety report id # (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MALEM ULTIMATE BEDWETTING ALARM
Type of Device
ALARM, CONDITIONED RESPOSNE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD.
MDR Report Key8674892
MDR Text Key147390489
Report NumberMW5087160
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 06/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberM043
Device Catalogue NumberULTIMATE BEDWETTING ALARM
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/05/2019
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age4 YR
-
-