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 MALEM; 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 MALEM; ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Device Problems Leak/Splash (1354); Overheating of Device (1437); Chemical Spillage (2894)
Patient Problem Chemical Exposure (2570)
Event Date 01/01/2018
Event Type  Injury  
Event Description
My daughter has autism and she wets the bed every time she sleeps.I bought the malem alarm for her.It has a battery driven alarm part which is connected on her neckline and a sensor which is clipped outside her panty.She took an afternoon nap with the alarm and sensor connected.I had put the same batteries that came with the malem alarm.It was the first time i was using this alarm on her.Within 15 mins, the alarm got very hot and she called me for help.When i reached her, the alarm had short circuited and batteries leaked on to her body and clothing.She was drenched in black color battery acid and it was very hot.I immediately took her to the er and just returned.They advised me to file a complaint with fda as this is a medical device.The product shorted out on its own.Red color.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MALEM
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL
MDR Report Key7159781
MDR Text Key96333415
Report NumberMW5074333
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 01/01/2018
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? No
Device Operator No Information
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/02/2018
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age3 YR
-
-