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 MALEM BED WETTING 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 MALEM BED WETTING ALARM Back to Search Results
Model Number BLUE COLOR SINGLE TONE
Device Problems Burst Container or Vessel (1074); Melted (1385); Temperature Problem (3022)
Patient Problem Burn, Thermal (2530)
Event Date 12/21/2016
Event Type  Injury  
Event Description
We purchased a bedwetting alarm and used it for the first time last night.The product is simple.It has a sensor and a compact alarm unit which connects to the sensor.The sensor is placed on the outside of the underwear and the alarm unit is clipped on the top of the t-shirt.I saw an ad on (b)(6) which directed me to the manufacturer's website - (b)(6).I purchased a malem bedwetting alarm for my (b)(6) son and we tried it for the first time last night.I set it up as per instructions and put my son to sleep.Within 10 minutes, the back of the alarm got so hot that it partially melted and burnt a hole through my son's pajama top.How can a bed wetting product do this? isn't there any quality control for this product? i had to rush my child to the emergency room and reported the incident today morning to the manufacturer who told me that it was a safe product and that this is user error.I just put in batteries and literally exploded.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MALEM BED WETTING ALARM
Type of Device
BED WETTING ALARM
Manufacturer (Section D)
MALEM
MDR Report Key6202820
MDR Text Key63241194
Report NumberMW5066897
Device Sequence Number1
Product Code KPN
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 12/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberBLUE COLOR SINGLE TONE
Was Device Available for Evaluation? Yes
Type of Device Usage N
Patient Sequence Number1
Treatment
OTC MEDS: CENTRUM KIDS.; RX MEDS: NA
Patient Outcome(s) Required Intervention;
Patient Age8 YR
-
-