BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK SERI SURGICAL SCAFFOLD

    MDR report key: 4092028 · Received August 21, 2014

    Report

    Report Number
    3008374097-2014-00064
    Event Type
    Injury
    Date Received
    August 21, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 22, 2014
    Manufacturer
    ALLERGAN
    Product Code
    OXF
    PMA / PMN Number
    K123128
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFO FROM THE REPORTER REGARDING THE EVENT AND PRODUCT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. DEVICE AVAILABILITY FOR RETURN IS UNK. THE EVENT OF SEROMA IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. 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 IN THE BREAST WITH A CONCOMITANT TISSUE EXPANDER DURING RECONSTRUCTIVE SURGERY. POST IMPLANT, PT PRESENTED WITH A SEROMA. SERI AND TISSUE EXPANDER WERE FULLY EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504672 UNK SERI SURGICAL SCAFFOLD OXF ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention IMPLANTED WITH A CONCOMITANT TISSUE EXPANDER