BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRISTEM SURGICAL MATRIX PSMT

    MDR report key: 3890755 · Received June 12, 2014

    Report

    Report Number
    3005920706-2014-00006
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    March 20, 2014
    Report Date
    May 13, 2014
    Manufacturer
    ACELL INC.
    Product Code
    FTM
    PMA / PMN Number
    K041140
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY CONDUCTED ON DISCOVERY. NO SUBSTANTIAL DEVIATION WAS IDENTIFIED AND ALL RECORDS PURPORT THE PRODUCT WAS MANUFACTURED AND DISTRIBUTED STERILE IN COMPLIANCE WITH FDA, STATE, LOCAL, AND MANUFACTURER OPERATING PROCEDURES. THE PRODUCT LOT MET ALL REQUIRED RELEASE CRITERIA AND THERE WAS NO REPORT OF DEVICE FAILURE AT THE TIME OF SURGERY.

    Description of Event or Problem · 1

    MATRISTEM SURGICAL MESH DEVICE WAS UTILIZED IN A LIPO-ABDOMINOPLASTY WITH A VENTRAL HERNIA REPAIR SURGERY ON (B)(6) 2014. THE MATRISTEM PRODUCT WAS USED AS AN UNDERLAYMENT CONCOMITANTLY WITH A PRODUCT FROM A DIFFERENT MANUFACTURER. SEVERAL WEEKS LATER, THE PT SUBSEQUENTLY DEVELOPED A SEROMA WHICH WAS DRAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348263 MATRISTEM SURGICAL MATRIX PSMT FTM, SURGICAL MESH FTM ACELL INC. OM1077-804

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention XENMATRIX USED AS AN OVERLAY DURING,| INITIAL PROCEDURE :