BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOHNSON AND JOHNSON FIRST AID SECURE-FLEX WRAP

    MDR report key: 3786594 · Received May 2, 2014

    Report

    Report Number
    2214133-2014-00009
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    March 30, 2014
    Report Date
    April 7, 2014
    Manufacturer
    SKILLMAN CONTRACT
    Product Code
    FRG
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2014 FROM A (B)(6) CAUCASIAN FEMALE CONSUMER ((B)(6), HEIGHT UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. THE MEDICAL HISTORY INCLUDED DEPRESSION, ALLERGIES TO PEANUTS, DUST AND DANDER AND SENSITIVITY TO SOME DETERGENTS. THE CONCOMITANT MEDICATIONS INCLUDED CETIRIZINE ONCE DAILY, SINCE YEARS FOR ALLERGIES AND FLUOXETINE 20 MILLIGRAMS, ONCE DAILY, SINCE ONE TO TWO YEARS FOR DEPRESSION. ON (B)(6) 2014, THE CONSUMER STARTED USING JOHNSON AND JOHNSON FIRST AID SECURE-FLEX WRAP CUTANEOUSLY, FIVE WRAPS, USED CONSTANTLY FOR THREE DAYS FOR A BURN ON ARM (LOT NUMBER AND EXPIRATION DATE UNSPECIFIED). ON (B)(6) 2014, SHE EXPERIENCED ITCHING, FOLLOWED BY HIVES ON THE NEXT DAY AND SWELLING OF HER ARM TWO DAYS AFTER THE FIRST EVENT. ON (B)(6) 2014, SHE PRESENTED TO THE EMERGENCY ROOM WHERE SHE RECEIVED A STEROID SHOT AND WAS ALSO PRESCRIBED AN UNSPECIFIED STEROID CREAM BY THE PHYSICIAN TO TREAT THE EVENTS. ON (B)(6) 2014, THE USE OF THE DEVICE WAS DISCONTINUED. AFTER AN UNSPECIFIED DURATION, THE EVENT OF SWELLING RESOLVED BUT THE EVENTS OF ITCHING AND HIVES DID NOT RESOLVE. A REVIEW OF THE COMPLAINT DATA REVEALED NO UNFAVORABLE TRENDS. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED. THIS REPORT WAS ASSESSED AS SERIOUS (REQUIRED INTERVENTION) AND COMPANY CAUSALITY WAS ASSESSED AS RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264648 JOHNSON AND JOHNSON FIRST AID SECURE-FLEX WRAP STERILIZATION WRAP FRG SKILLMAN CONTRACT JJFASFUS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention