BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERI SURGICAL SCAFFOLD (US)

    MDR report key: 4223541 · Received October 29, 2014

    Report

    Report Number
    3008374097-2014-00106
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    July 21, 2014
    Report Date
    October 1, 2014
    Manufacturer
    ALLERGAN
    Product Code
    OXF
    PMA / PMN Number
    K123128
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT DETAILS HAVE BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENTS OF ERYTHEMA SYNDROME, ERYTHEMA, EDEMA, AND HEMATOMA ARE PHYSIOLOGICAL COMPLICATIONS, AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. THE PHYSICIAN DECLINED ALLERGAN'S REQUEST TO RETURN THE DEVICE. THEREFORE, ALLERGAN WILL NOT RECEIVE THE DEVICE AND NO ANALYSIS OR TESTING WILL BE DONE. THESE EVENTS ARE BEING REPORTED BECAUSE MEDICAL INTERVENTION WAS REQUIRED, ALTHOUGH DEVICE-RELATEDNESS HAS NOT BEEN ESTABLISHED.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED IMPLANTATION OF SERI AND CONCOMITANT BREAST IMPLANTS ON (B)(6) 2014 DURING BILATERAL AUGMENTATION MASTOPEXY SURGERY. POST-IMPLANTATION ON (B)(6) 2014, PATIENT PRESENTED WITH BILATERAL REDNESS, AND LATER THE RIGHT BREAST BECAME "SWOLLEN AND RED" AND "HAD TO DRAIN LONGER THAN NORMAL FOR FLUID BUILD UP." TREATMENT INCLUDED EXPLORATORY SURGERY AND PARTIAL REMOVAL OF THE SERI ON (B)(6) 2014. THE HEALTHCARE PROFESSIONAL NOTED "OLD BLOOD DISCOVERED" DURING ADDITIONAL EXPLORATORY SURGERY ON (B)(6) 2014. DEVICE REMAINS PARTIALLY IMPLANTED AND IS UNAVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692173 SERI SURGICAL SCAFFOLD (US) OXF ALLERGAN NA P13081301A

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention PATIENT WAS IMPLANTED WITH CONCOMITANT ALLERGAN| SILICONE BREAST IMPLANTS, WHICH REMAIN IMPLANTED