BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRISTEM SURGICAL MATRIX PSMX

    MDR report key: 2892184 · Received December 21, 2012

    Report

    Report Number
    3005920706-2012-00013
    Event Type
    Injury
    Date Received
    December 21, 2012
    Report Date
    November 21, 2012
    Manufacturer
    ACELL INC.
    Product Code
    FTM
    PMA / PMN Number
    K041140
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACELL HAS SPOKEN TO THE SURGEON. BASED ON ITS REVIEW THUS FAR, ACELL IS NOT AWARE OF ANY CLINICAL OR PATHOLOGICAL EVIDENCE INDICATING ITS PRODUCT WAS RELATED TO THE NEED FOR PARTIAL EXPLANT. THIS MDR IS BEING SUBMITTED OUT OF AN ABUNDANCE OF CAUTION. ACELL IS IN THE PROCESS OF CONTINUING ITS COMPLAINT INVESTIGATION.

    Description of Event or Problem · 1

    PHYSICIAN IMPLANTED IMMUNOCOMPROMISED PATIENT WITH MATRISTEM SURGICAL MATRIX PSMX AS AN ONLAY (ANTERIOR TO FASCIA, POSTERIOR TO SUBCUTANEOUS TISSUE) IN (B)(6) 2012 FOLLOWING ABDOMINAL WALL COMPONENT SEPARATION FOR HERNIA REPAIR, WHICH WAS REQUIRED AFTER SURGICAL TRANSPLANT OF AN UNKNOWN ORGAN. PATIENT ACCUMULATED AN UNKNOWN AMOUNT OF SEROUS FLUID IN THE ABDOMEN AT AN UNDISCLOSED TIME FOLLOWING INITIAL SURGERY. PATIENT WAS TAKEN TO THE OPERATING ROOM ON (B)(6) 2012. DEEPER LAYERS OF THE DEVICE WERE FOUND TO BE INCORPORATED, WHILE SUPERFICIAL LAYERS REMAINED. THE REMAINING SUPERFICIAL LAYERS OF THE DEVICE WERE MANUALLY REMOVED. THERE WERE NO SIGNS OF INFECTION. A SMALL RECURRENT HERNIA WAS FOUND UNDER THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRISTEM SURGICAL MATRIX PSMX FTM, SURGICAL MESH FTM ACELL INC. OM302-805

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R