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 CORP. MALEM BED-WETTING ALARM; ALARM CONDITIONED 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 CORP. MALEM BED-WETTING ALARM; ALARM CONDITIONED RESPONSE ENURESIS Back to Search Results
Model Number BLUE COLOR 1 TONE
Device Problems Leak/Splash (1354); Overheating of Device (1437)
Patient Problems Rash (2033); Skin Irritation (2076)
Event Date 04/26/2018
Event Type  No Answer Provided  
Event Description
We were using a bedwetting alarm for a month and had some problems with it.We then moved to the malem alarm and last night was the first night we actually used the alarm.It was a very bad experience.I set it up on my (b)(6) year old girl and when i came in to check on her 45 minutes later, i noticed that the alarm had black liquid coming out from it.The batteries had leaked.The alarm was also very hot.This is a malfunction in the alarm.Our previous alarm did not do such a thing.I woke up my daughter and removed the alarm.I noticed that she has a skin rash from the battery leak and had small red patch on her body.I took her to the clinic next morning and they advised me to report this to the fda.The malem alarm has caused this problem.It gets hot and the batteries leak on the body.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MALEM BED-WETTING ALARM
Type of Device
ALARM CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL CORP.
MDR Report Key7475120
MDR Text Key107102802
Report NumberMW5076898
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 04/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberBLUE COLOR 1 TONE
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age3 YR
Patient Weight15
-
-