BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTELLA

    MDR report key: 9413524 · Received December 4, 2019

    Report

    Report Number
    3010513348-2019-00012
    Event Type
    Injury
    Date Received
    December 4, 2019
    Date of Event
    November 4, 2019
    Report Date
    December 4, 2019
    Manufacturer
    AROA BIOSURGERY
    Product Code
    FTM
    UDI-DI
    09421905067034
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PATIENT UNDERWENT A BILATERAL MASTECTOMY WITH IMMEDIATE DIRECT TO IMPLANT PREPECTORAL BREAST RECONSTRUCTION ON (B)(6) 2019. THE BREAST IMPLANTS WERE ANTERIORLY COVERED WITH RESTELLA RESORBABLE (PGA). THE PATIENT EXHIBITED DRAINAGE OF OPAQUE FLUID ON BOTH SIDES. SWELLING AND REDNESS DEVELOPED, FIRST ON THE RIGHT BREAST ON (B)(6) 2019 (32 DAYS POST OP) ON THE LOWER POLE. AS A PRECAUTION THE PATIENT WAS TAKEN TO THE OR AND THE RIGHT BREAST IMPLANT AND RESTELLA RESORBABLE WERE REMOVED. THREE DAYS LATER THE SURGEON NOTICED A SIMILAR PATTERN ON THE LEFT BREAST. THE PATIENT RETURNED TO THE OR THAT DAY AND THE LEFT BREAST IMPLANT AND RESTELLA RESORBABLE WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1202916 RESTELLA SURGICAL MESH FTM AROA BIOSURGERY ERT-9E02 09421905067034

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| R