BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERI SURGICAL SCAFFOLD (US)

    MDR report key: 4223199 · Received October 27, 2014

    Report

    Report Number
    3008374097-2014-00120
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    September 20, 2014
    Report Date
    September 26, 2014
    Manufacturer
    ALLERGAN
    Product Code
    OXF
    PMA / PMN Number
    K123128
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENTS OF INADEQUATE TISSUE INGROWTH AND ABSCESS ARE PHYSIOLOGICAL COMPLICATIONS, AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. THE PHYSICIAN DISCARDED THE DEVICE WHEN IT WAS EXPLANTED AND IT IS NO LONGER AVAILABLE FOR RETURN. THEREFORE, ALLERGAN WILL NOT RECEIVE THE DEVICE AND NO ANALYSIS OR TESTING WILL BE DONE. 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 RIGHT SIDE IMPLANTATION OF SERI ON (B)(6) 2014 DURING MASTOPEXY SURGERY. POST-IMPLANTATION, PATIENT PRESENTED ON (B)(6) 2014 WITH A "STERILE ABSCESS". TREATMENT INCLUDED REMOVAL OF THE DEVICE ON (B)(6) 2014, AND UPON EXPLANT, THE DEVICE WAS FOUND TO BE "NOT AT ALL" INCORPORATED WITH THE PATIENT'S TISSUE. THE DEVICE IS UNAVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE IMPLANTATION OF SERI ON (B)(6) 2014 DURING MASTOPEXY SURGERY. POST-IMPLANTATION, PATIENT PRESENTED ON (B)(6) 2014 WITH A "STERILE ABSCESS". TREATMENT INCLUDED REMOVAL OF THE DEVICE ON (B)(6) 2014, AND UPON EXPLANT, THE DEVICE WAS FOUND TO BE "NOT AT ALL" INCORPORATED WITH THE PATIENT'S TISSUE. THE DEVICE IS UNAVAILABLE FOR RETURN. THE HEALTHCARE PROFESSIONAL REPORTED ADDITIONALLY THAT THE PATIENT EXPERIENCED "PURULENT DRAINAGE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681383 SERI SURGICAL SCAFFOLD (US) MESH, SURGICAL, ABSORBABLE, PLASTIC AND RECONSTRUCTIVE SURGERY OXF ALLERGAN NA P12102201A

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention