BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERISCAFFOLD SURGICAL SCAFOLD (OUS)

    MDR report key: 4092052 · Received August 21, 2014

    Report

    Report Number
    3008374097-2014-00062
    Event Type
    Injury
    Date Received
    August 21, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 22, 2014
    Manufacturer
    ALLERGAN
    Product Code
    OXF
    PMA / PMN Number
    K123128
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPLANTED DEVICE IS NOT AVAILABLE FOR RETURN. THE EVENT OF ERYTHEMA IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THE EVENT. THESE EVENTS ARE BEING REPORTED BECAUSE MEDICAL 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 PT REPORTED UNDER MDR ID #3008374097-2014-00070 (ALLERGAN COMPLAINT PR#(B)(4)).

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED IMPLANTATION OF SERI WITH A CONCOMITANT TISSUE EXPANDER ON (B)(6) 2014 DURING BILATERAL RECONSTRUCTION SURGERY. POST IMPLANT ON (B)(6) 2014, PATIENT PRESENTED WITH REDNESS OF THE LEFT BREAST, AND WAS PRESCRIBED POST-OPERATIVE ANTIBIOTICS. PHYSICIAN DEFLATED THE TISSUE EXPANDER, BUT WITH NO IMPROVEMENT TO SYMPTOMS. SERI AND TISSUE EXPANDER WERE FULLY EXPLANTED ON (B)(6) 2014, WITH ADDITIONAL TREATMENT INCLUDING WASHINGTON OF THE BREAST POCKET AND INTRAVENOUS ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504941 SERISCAFFOLD SURGICAL SCAFOLD (OUS) OXF ALLERGAN NA P12102301

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention EXPLANTED:| CONCOMITANT TISUE EXPANDER| IMPLANTED: