BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERISCAFFOLD SURGICAL SCAFFOLD (OUS)

    MDR report key: 4121272 · Received September 22, 2014

    Report

    Report Number
    3008374097-2014-00094
    Event Type
    Injury
    Date Received
    September 22, 2014
    Date of Event
    January 26, 2014
    Report Date
    January 26, 2014
    Manufacturer
    ALLERGAN
    Product Code
    OXF
    PMA / PMN Number
    K123128
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED. THE EVENT OF "WOUND BREAK DOWN (MINOR) AND DISCHARGE" ARE PHYSIOLOGICAL COMPLICATIONS 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. THIS EVENT IS REPORTED AGAINST THE LEFT SIDE, AND IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID #3008374097-2014-00095 (ALLERGAN COMPLAINT PR# (B)(4)).

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED A RECURRENCE OF WOUND DEHISCENCE BEGINNING (B)(6) 2014 IN THE LEFT BREAST. THE PATIENT REQUIRED HOSPITALIZATION FOR TREATMENT.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED IMPLANTATION OF SERI WITH A CONCOMITANT COHESIVE SILICONE GEL BREAST IMPLANT ON (B)(6) 2013 DURING PRIMARY BREAST RECONSTRUCTION. POST IMPLANT ON (B)(6) 2014, THE PATIENT EXPERIENCED BILATERAL "WOUND BREAK DOWN (MINOR) AND DISCHARGE" REQUIRING HOSPITALIZATION. CONCOMITANT BREAST DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2014. SERI DEVICE REMAINS IMPLANTED. PATIENT WAS ADDITIONALLY TESTED WITH ORAL CIPROFLOXACIN AND PARACETAMOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587802 SERISCAFFOLD SURGICAL SCAFFOLD (OUS) MESH, SURGICAL, ABSORBABLE, PLASTIC AND RECONSTRUCTIVE SURGERY OXF ALLERGAN NA P12082701B

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R EXPLANTED:| BREAST IMPLANT: