BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INPLANT FUNNEL

    MDR report key: 11797313 · Received May 10, 2021

    Report

    Report Number
    3013980229-2021-70015
    Event Type
    Injury
    Date Received
    May 10, 2021
    Date of Event
    May 15, 2020
    Report Date
    June 17, 2020
    Manufacturer
    PROXIMATE CONCEPTS LLC
    Product Code
    KDD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS A RESPONSE TO MEDWATCH REPORT MW5095092. PROXIMATE CONCEPTS PERFORMED A MANUFACTURING RECORD EVALUATION (MRE) ON THE LOT OF INPLANT FUNNELS PROVIDED IN THE ORIGINAL MEDWATCH REPORT. THE MRE CONCLUDED THAT ALL INPLANT FUNNELS IN LOT 040220 WERE MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. AS A RESULT OF PROXIMATE CONCEPTS' INVESTIGATION, THE CAUSE OF THE ADVERSE EVENT CANNOT BE TRACED BACK TO THE INPLANT FUNNEL. AS SUCH, THIS COMPLAINT WILL BE CLOSED. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    ON 06/17/2020 A SURGEON SUBMITTED A VOLUNTARY REPORT TO THE FDA (MW5095092) REGARDING AN ADVERSE EVENT THAT OCCURRED 10 DAYS POST BREAST AUGMENTATION SURGERY. THE DATE OF SURGERY WAS (B)(6) 2020. ACCORDING TO THE SURGEON, THE PATIENT BEGAN TO SPIKE INTO HIGH FEVERS (>102) OF UNKNOWN ORIGIN. 4 DAYS LATER, THE PATIENT'S RIGHT INCISION DEVELOPED A PINHOLE INCISION AND BEGAN DRAINING BROWNISH FLUID. THE SURGEON TOOK THE PATIENT BACK TO THE OPERATING ROOM FOR A WASHOUT AND IMPLANT REPLACEMENT. THE SURGEON INDICATED THAT THE PATIENT GREW OUT SERRATIA MARCESCENS AS PER CULTURE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694268 INPLANT FUNNEL INPLANT FUNNEL KDD PROXIMATE CONCEPTS LLC IN-001 040220

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other