BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALOE VESTA 2NL BODY WASH/SHMP

    MDR report key: 4147028 · Received October 2, 2014

    Report

    Report Number
    1049092-2014-00518
    Event Type
    Injury
    Date Received
    October 2, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 11, 2014
    Manufacturer
    CONVATEC, INC.
    Product Code
    FRO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. PER THE INFO RECEIVED, THE FACILITY HAS ONLY HAD THE PRODUCT IN HOUSE FOR NO LONGER THAN ONE MONTH. ADD'L INFO HAS BEEN REQUESTED, HOWEVER, NO ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADD'L INFO BECOME AVAILABLE, A F/U REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON 10/02/2014. NOTE: THE DATE OF EVENT WAS NOT PROVIDED, THEREFORE, THE DATE USED WAS THE DATE CONVATEC BECAME AWARE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE END USER DEVELOPED RASH ON ENTIRE BODY AFTER USING ALOE VESTA BODY WASH AND SHAMPOO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617450 ALOE VESTA 2NL BODY WASH/SHMP SKIN CLEANSER FRO CONVATEC, INC. 324609 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1