BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALOE VESTA PROTECTIVE OINTMENT (AVPO)

    MDR report key: 3975177 · Received July 2, 2014

    Report

    Report Number
    1049092-2014-00258
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 6, 2014
    Manufacturer
    CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C.
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A SERIOUS INJURY. THEN NURSE HAS BEEN CONTACTED VIA VOICEMAIL TO GATHER FURTHER INFO REGARDING THESE CASES. THE TERRITORY MGR (TM) IS INVOLVED IN THE CASE AND IS ASSISTING CONVATEC TO ASCERTAIN ADDITIONAL INFO. NO ADDITIONAL EVENT/PT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. SHOULD ADDITIONAL INFO BECOME AVAILABLE, A FOLLOW-U P REPORT WILL BE SUBMITTED. PLEASE NOTE: THERE WERE THREE (3) PICU PATIENTS AFFECTED; THEREFORE A SEPARATED FDA 3500A FORM HAS BEEN GENERATED TO ADDRESS THE OTHER TWO (2) CASES REPORTED UNDER PT IDENTIFIER(S): (B)(6). REPORTED TO THE FDA ON 07/01/2014. NOTE: THE ACTUAL DATE OF EVENT IS UNK, 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 · 1

    IT IS REPORTED THAT THREE (3) CASES OF PEDIATRIC END-USERS IN PEDIATRIC INTENSIVE CARE UNIT (PICU) WITH A FOLEY CATHETER IN PLACE DEVELOPED CANDIDA INFECTION OF THE URINE AFTER THE USE OF ALOE VESTA PROTECTIVE OINTMENT TO THE PERIANAL AREA. IT IS FURTHER REPORTED THAT TWO (2) MORE DEVELOPED UNSPECIFIED BACTERIAL INFECTION IN URINE WHILE CATHETER IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386128 ALOE VESTA PROTECTIVE OINTMENT (AVPO) NONE EXE CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention