BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRISTEM PELVIC FLOOR MATRIX

    MDR report key: 6214402 · Received December 29, 2016

    Report

    Report Number
    3005920706-2016-00008
    Event Type
    Injury
    Date Received
    December 29, 2016
    Date of Event
    November 26, 2016
    Report Date
    November 30, 2016
    Manufacturer
    ACELL, INC
    Product Code
    FTM
    PMA / PMN Number
    K141084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS CONDUCTED ON DISCOVERY. A REVIEW OF THE MANUFACTURING RECORDS FOR THE LOT IDENTIFIED NO SUBSTANTIAL DEVIATION AND DEMONSTRATED THAT THE PRODUCT WAS MANUFACTURED AND DISTRIBUTED IN COMPLIANCE WITH FDA, STATE, AND LOCAL LAWS, AS WELL AS ALL MANUFACTURER OPERATING PROCEDURES. THERE WAS NO REPORT OF DEVICE FAILURE FROM THE TREATING PHYSICIAN AT THE TIME OF SURGERY. A SISTER GRAFT FROM THE SAME LOT WAS TESTED FOR STERILITY AND RESULTS OF NO GROWTH SUBSTANTIATED THAT THE LOT WAS SUPPLIED STERILE. THIS MDR HAS BEEN FILED OUT OF AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    PATIENT DEVELOPED AN INFECTION APPROXIMATELY 8 DAYS AFTER A POSTERIOR VAGINAL WALL REPAIR IN WHICH THE SURGEON EMPLOYED AN ACELL DEVICE. PATIENT WAS ADMITTED INTO THE HOSPITAL AND ADMINISTERED INTRAVENOUS ANTIBIOTICS. PATIENT WAS DISCHARGED WITH ORAL ANTIBIOTICS ON (B)(6) 2016 AND HAS NOT SINCE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863302 MATRISTEM PELVIC FLOOR MATRIX MESH, SURGICAL FTM ACELL, INC PFM0912 SM7336-66

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization