BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERISCAFFOLD SURGICAL SCAFFOLD (OUS)

    MDR report key: 4142454 · Received October 1, 2014

    Report

    Report Number
    3008374097-2014-00090
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 13, 2014
    Report Date
    September 11, 2014
    Manufacturer
    ALLERGAN
    Product Code
    OXF
    PMA / PMN Number
    K123128
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPLANTED DEVICE IS NOT AVAILABLE FOR RETURN. THE EVENTS OF INFECTION, SEROMA, ULCER, EDEMA AND "UNINCORPORATED" ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. THIS 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 GET BREAST IMPLANT ON (B)(6) 2014 DURING LEFT SIDE MASTECTOMY RECONSTRUCTION SURGERY. POST-IMPLANTATION ON (B)(6) 2014, PATIENT PRESENTED REQUIRING "EVACUATION 500CC SEROSANGUINOUS SEROMA L BREAST THAT ACCUMULATED OVER SEVERAL DAYS AFTER THE REMOVAL OF THE DRAIN. CULTURE GREW ENTEROBACTER CLOACAE. ON LONG TERM ANTIBIOTICS FOR 2 MONTHS APPROPRIATE TO CULTURE. THREE MONTHS LATER ((B)(6) 2014) (1 MONTH AFTER CEASING ABS), DEVELOPED AN ULCER IN THE MASTECTOMY SCAR OF THIS BREAST." ON (B)(6) 2014, "EXCISION EXPOSED SERI WITHIN THE ULCER AND DEBRIDEMENT WITH CLOSURE. SWELLING OVERNIGHT." AND (B)(6) 2014, "EXPLANTATION AND REMOVAL SERI (COMPLETELY UNINCORPORATED)." THE DEVICE IS NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611666 SERISCAFFOLD SURGICAL SCAFFOLD (OUS) OXF ALLERGAN NA P13090901A

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention IMPLANT:| CONCOMITANT GEL IMPLANT