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 ALARM ULTIMATE BEDWETTING ALARM; ALARM, CONDTIONED RESPONSE 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 ALARM ULTIMATE BEDWETTING ALARM; ALARM, CONDTIONED RESPONSE ENURESIS Back to Search Results
Catalog Number M0472
Device Problems Leak/Splash (1354); Device Emits Odor (1425); Overheating of Device (1437); Material Twisted/Bent (2981)
Patient Problem No Patient Involvement (2645)
Event Date 07/17/2019
Event Type  Injury  
Event Description
This is a complaint for a brand new malem bedwetting alarm which i purchased from (b)(6).It comes with 2 batteries and a urine sensor.I purchased it for my (b)(6) son and was getting ready to test it.I just put in batteries and then connected the sensor.That was it.After that i got busy doing some other work.When i returned after an hour, there was a bad smell from the alarm and it was no longer working.The alarm had sticky liquid on the bottom which i think was the battery leak.The blue plastic battery sliding door was bent inside like from heat.The alarm won't operate now.I think it just self burnt its own and by itself.So scary that this happened when it was not in use.There is no way my son would be able to get up to this at night when he was sleeping.It has been returned to amazon.Fda safety report id #(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MALEM ALARM ULTIMATE BEDWETTING ALARM
Type of Device
ALARM, CONDTIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD.
MDR Report Key8822836
MDR Text Key152181795
Report NumberMW5088341
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 07/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberM0472
Was Device Available for Evaluation? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age6 YR
-
-