BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALOE VESTA - ALOE VESTA 2N1 BODY WASH/SHMP

    MDR report key: 18670032 · Received May 6, 2014

    Report

    Report Number
    2243969-2014-00229
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 11, 2014
    Manufacturer
    CONVATEC, INC.
    Product Code
    KOY
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. PATIENT WAS RECOMMENDED THAT SHE SEE A PHYSICIAN. IT IS REPORTED THAT PATIENT COULD NOT FIND THE LOT NUMBER ON THE BOTTLE. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON MAY 6, 2014. FDA REGISTRATION NUMBER REPORTING SITE: 2243969. THIRD PARTY MANUFACTURER: MEDICIA HOLDINGS, LLC 2351 U.S. ROUTE 130, DAYTON, NJ 08810. NOTE: THE ACTUAL DATE OF EVENT IS UNKNOWN, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S. COMPLAINT HANDLING AND CAPA PROCEDURES.

    Description of Event or Problem · 0

    PATIENT REPORTED THAT WHILE IN THE HOSPITAL IN MID (B)(6) 2014, THE STAFF WASHED HER HAIR WITH THE PRODUCT UNDILUTED. HER SCALP BEGAN TO BURN AND SHE STATED THAT HER EYES, FACE AND LIPS BECAME SWOLLEN, RED AND ITCHY. THE PATIENT INDICATED THAT SHE TOLD THE STAFF BUT THEY CONTINUED TO USE THE PRODUCT. THE PATIENT DID NOT SEE A PHYSICIAN FOR THE ISSUE. SHE HAS BEEN RELEASED FROM THE HOSPITAL AT THE END OF FEBRUARY AND NO LONGER USED THE PRODUCT ON HER SCALP BUT USED IT AS A BODY WASH, AND STATED THAT HER HAIR IS NOW COMING OUT IN CLUMPS AND HER SCALP BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131368 ALOE VESTA - ALOE VESTA 2N1 BODY WASH/SHMP COSMETIC KOY CONVATEC, INC. 324609 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention