BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERI SURGICAL SCAFFOLD (US)

    MDR report key: 4093552 · Received September 3, 2014

    Report

    Report Number
    3008374097-2014-00073
    Event Type
    Injury
    Date Received
    September 3, 2014
    Date of Event
    July 8, 2014
    Report Date
    August 4, 2014
    Manufacturer
    ALLERGAN
    Product Code
    OXF
    PMA / PMN Number
    K123128
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPLANTED DEVICE HAS BEEN DISCARDED. FURTHER INFO FROM THE REPORTER REGARDING THE EVENT AND PRODUCT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. THE EVENT OF SEROMA IS SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. THESE EVENTS ARE BEING REPORTED BECAUSE MED INTERVENTION WAS REQUIRED, ALTHOUGH DEVICE-RELATEDNESS HAS NOT BEEN ESTABLISHED. THIS EVENT IS REPORTED AGAINST THE LEFT SIDE, AND IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR #30083474097-2014-00072 (ALLERGAN COMPLAINT PR# (B)(4)).

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED IMPLANTATION OF SERI WITH A CONCOMITANT SILICONE BREAST IMPLANT ON (B)(6) 2014 DURING A PROPHYLACTIC MASTECTOMY AND BREAST RECONSTRUCTION SURGERY. POST-IMPLANTATION ON (B)(6) 2014, PATIENT PRESENTED IN THE LEFT BREAST WITH "DEHISCENCE OF THE INCISION" AND SEROMA. PHYSICIAN ELECTED TO PERFORM A TISSUE DEBRIDEMENT WITH PLACEMENT OF DRAINS AND CLOSURE OF THE DEHISCED INCISION; HOWEVER, DURING SURGERY ON (B)(6) 2014, PHYSICIAN NOTED A "TEAR IN THE CAUDAL PORTION" AND NON-INCORPORATION OF THE SERI DEVICE, AND AN INFLAMMATORY RESPONSE IN THE BREAST POCKET. SERI WAS FULLY EXPLANTED AND DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537303 SERI SURGICAL SCAFFOLD (US) OXF ALLERGAN NA P12091001

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention EXPLANT DATE:| IMPLANT DATE:| SILICONE BREAST IMPLANT,