BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERI SURGICAL SCALFOLD (US)

    MDR report key: 4213011 · Received October 24, 2014

    Report

    Report Number
    3008374097-2014-00108
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    August 12, 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 INFO FROM THE REPORTER REGARDING THE EVENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. THE EVENT OF ERYTHEMA SYNDROME IS A PHYSIOLOGICAL COMPLICATION, AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THE EVENT. THE EVENT IS 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 IMPLANT ON (B)(6) 2014 DURING LEFT SIDE AUGMENTATION MASTOPEXY SURGERY. POST-IMPLANTATION ON (B)(6) 2014, PT PRESENTED WITH REDNESS IN THE LEFT BREAST. THE REDNESS WAS ISOLATED TO THE SKIN DIRECTLY OVERLYING THE SERI TREATMENT INCLUDED SILVADENE AND ANTIBIOTICS. DEVICE REMAINS IMPLANTED AND IS UNAVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678584 SERI SURGICAL SCALFOLD (US) OXF ALLERGAN NA P12102201A

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention PATIENT WAS CONCOMITANTLY IMPLANTED WITH| ALLERGAN SILICONE IMPLANTS.