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 BEDWETTING ALARM
  • 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 BEDWETTING ALARM Back to Search Results
Device Problems Melted (1385); Temperature Problem (3022)
Patient Problem Burn, Thermal (2530)
Event Date 07/31/2017
Event Type  Injury  
Event Description
When the malem bedwetting alarm arrived, i went through the instructions with my (b)(6) son.We explained him how to use the product so he could stop wetting the bed.First day of use was not bad but my son told me that he was finding the alarm a little hot.I thought it must be regular, but the second night terrified me when i heard his loud scream, and he was literally jumping on the bed with a big red patch on his neck and was in a lot of pain.I touched the alarm and found that at the back of the alarm the battery door had melted and it was a nightmare to touch it as it was as hot as burning coal.I had a hard time taking care of my son with home remedies till ran to my doctor early morning for his treatment.I am filing this complaint to let you know that a dangerous product like the malem alarm can be life threatening to any child.It is a cheaply made product that needs to be recalled from the market as soon as possible.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MALEM BEDWETTING ALARM
Type of Device
MALEM BEDWETTING ALARM
Manufacturer (Section D)
MALEM MEDICAL LTD
MDR Report Key6773098
MDR Text Key82122312
Report NumberMW5071405
Device Sequence Number1
Product Code KPN
Combination Product (y/n)N
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 08/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/04/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age6 YR
-
-