BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK SERI SURGICAL SCAFFOLD

    MDR report key: 5270363 · Received December 7, 2015

    Report

    Report Number
    8020862-2015-00021
    Event Type
    Injury
    Date Received
    December 7, 2015
    Report Date
    February 13, 2014
    Manufacturer
    ALLERGAN (MEDFORD)
    Product Code
    OXF
    PMA / PMN Number
    K123128
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON 12/07/2015. THE REPORTER HAS DECLINED TO PROVIDE ALLERGAN FURTHER INFORMATION REGARDING EVENT, PRODUCT, OR PATIENT DETAILS. THE EVENT OF "INFECTION" IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. THE DEVICE HAS NOT BEEN RETURNED. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF INFECTION AS FOLLOWS: "ADVERSE REACTIONS ARE THOSE TYPICALLY ASSOCIATED WITH SURGICALLY IMPLANTABLE MATERIALS, INCLUDING INFECTION, INFLAMMATION, ADHESION FORMATION, FISTULA FORMATION, AND EXTRUSION." THIS EVENT IS BEING REPORTED BECAUSE IT MAY HAVE LED TO MEDICAL INTERVENTION, ALTHOUGH DEVICE-RELATEDNESS HAS NOT BEEN ESTABLISHED.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "PLACEMENT OF SERI, INFECTION OCCURRED." THE INFECTION'S LOCATION IS UNKNOWN. TREATMENT FOR THE INFECTION IS UNKNOWN. SEE MFR REPORT # 8020862-2015-00022 FOR THE RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802261 UNK SERI SURGICAL SCAFFOLD MESH, SURGICAL, ABSORBABLE, PLASTIC AND RECONSTRUCTIVE SURGERY OXF ALLERGAN (MEDFORD) NI

    Patients

    Seq Age Sex Outcome Treatment
    1