BEUDAMED
    FDA Adverse Event Summary report: N

    FLEXHD - 8CM X 16CM

    MDR report key: 1982419 · Received January 14, 2011

    Report

    Report Number
    3001236616-2011-00003
    Date Received
    January 14, 2011
    Date of Event
    June 28, 2010
    Report Date
    January 26, 2011
    Manufacturer
    MTF
    Product Code
    GAT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: LOT#: 1029A, EXP DATE: 02/12/2013.

    Description of Event or Problem · 1

    ON (B)(6), 2010, THE PT HAD A BI-LATERAL IMPLANT PROCEDURE. ON (B)(6), 2010, THE PT RETURNED FOR INCISION DRAINAGE. ON (B)(6), 2010, THE PT UNDERWENT BI-LATERAL REMOVAL; BOTH THE MESH AND THE EXPANDERS WERE ALSO REMOVED AND THE SURGICAL SITE WAS IRRIGATED. IT IS CURRENTLY UNK IF CULTURES WERE OBTAINED. ADDITIONAL INFO HAS BEEN REQUESTED; NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXHD - 8CM X 16CM MTF HUMAN ALLOGRAFT GAT MTF 1028A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O