BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTRIX SURGICAL MATRIX THIN

    MDR report key: 8484988 · Received April 4, 2019

    Report

    Report Number
    3005920706-2019-00004
    Event Type
    Injury
    Date Received
    April 4, 2019
    Report Date
    March 6, 2019
    Manufacturer
    ACELL, INC.
    Product Code
    FTM
    PMA / PMN Number
    K162559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED DUE TO THE REPORTED SEROMA FORMATION AFTER INITIAL PLACEMENT OF THE ACELL DEVICE. IT IS UNKNOWN WHEN THE ACELL DEVICE WAS IMPLANTED AND IF IT WAS EXPLANTED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT IDENTIFIED NO DEVIATIONS IN THE PRODUCTION PROCESS THAT FALL OUTSIDE OF SPECIFICATION.

    Description of Event or Problem · 1

    ON 3/6/2019, ACELL, INC. WAS NOTIFIED BY A SURGEON THAT A PATIENT EXPERIENCED A SEROMA POST OPERATIVE AFTER A HIATAL HERNIA REPAIR PROCEDURE WITH AN ACELL DEVICE, DATE OF PROCEDURE WAS NOT PROVIDED. THE PATIENT REQUIRED REOPERATION FOR OTHER REASONS; IT IS UNKNOWN IF THE REOPERATION WAS RELATED TO THE SEROMA. SURGEON USED THE ACELL DEVICE PROPHYLACTICALLY ON A MIDLINE LAPAROTOMY CLOSURE; THE LAPAROTOMY WAS CREATED TO PERFORM HIATAL HERNIA REPAIR BUT NOT USED TO REINFORCE THE HIATUS. THE SURGEON PREFERS TO INSERT THE DEVICE IN THE VALLEY OF THE DEFECT AND THEN CLOSE THE SUBCUTANEOUS FLAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276369 GENTRIX SURGICAL MATRIX THIN GENTRIX SURGICAL MATRIX THIN FTM ACELL, INC. PSM0412 010293

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Other