BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERI SURGICAL SCAFFOLD (US)

    MDR report key: 5719943 · Received June 13, 2016

    Report

    Report Number
    8020862-2016-00032
    Event Type
    Injury
    Date Received
    June 13, 2016
    Date of Event
    May 22, 2016
    Report Date
    May 23, 2016
    Manufacturer
    ALLERGAN (MEDFORD)
    Product Code
    OXF
    PMA / PMN Number
    K123128
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. THE EVENT OF INADEQUATE TISSUE INGROWTH IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON 08/09/2016. THE DEVICE HAS BEEN DISCARDED AND WILL NOT BE RETURNED. INVESTIGATION HAS DETERMINED THAT THE INFORMATION SUBMITTED IN MEDWATCH REPORT 8020862-2016-00033 WAS DUPLICATED IN THIS REPORT. ALL ADDITIONAL INFORMATION REGARDING THIS DEVICE WILL BE SUBMITTED UNDER THIS REPORT NUMBER 8020862-2016-00032.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED SERI® SURGICAL SCAFFOLD WAS PLACED IN THE LEFT BREAST DURING MASTOPEXY ON (B)(6) 2014. POST-IMPLANTATION, THE DEVICE "DID NOT ABSORB", AND WAS REMOVED ON (B)(6) 2016.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED SERI® SCAFFOLD PLACED IN THE LEFT BREAST "DID NOT ABSORB". SERI® WAS INITIALLY PLACED BILATERALLY TO AMELIORATE "BOTTOMING OUT" OF PREVIOUSLY PLACED SILICONE GEL BREAST IMPLANTS. NO COMPLAINT WAS NOTED AGAINST THE SERI® SCAFFOLD PLACED ON THE RIGHT SIDE. THE LEFT SIDE SERI® WAS REMOVED AND THE EVENT HAS RESOLVED WITHOUT SEQUELAE. LEFT AND RIGHT SIDE SILICONE GEL BREAST IMPLANTS REMAIN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375803 SERI SURGICAL SCAFFOLD (US) MESH, SURGICAL, ABSORBABLE, PLASTIC AND RECONSTRUCTIVE SURGERY OXF ALLERGAN (MEDFORD) P12102201A

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention