BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRISTEM PLASTIC SURGERY MATRIX XS

    MDR report key: 2846261 · Received November 20, 2012

    Report

    Report Number
    3005920706-2012-00012
    Event Type
    Injury
    Date Received
    November 20, 2012
    Report Date
    October 21, 2012
    Manufacturer
    ACELL, INC.
    Product Code
    FTM
    PMA / PMN Number
    K041140
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACELL HAS SPOKEN TO SURGEON. BASED ON DISCUSSION WITH THE SURGEON, ACELL IS NOT AWARE OF ANY CLINICAL OR PATHOLOGICAL EVIDENCE INDICATING ITS PRODUCT WAS RELATED TO THE NEED FOR EXPLANT. PT WAS IMPLANTED WITH MATRISTEM PLASTIC SURGERY MATRIX XS IN THE RIGHT BREAST IN A POST-MASTECTOMY RECONSTRUCTION PROCEDURE ON (B)(6) 2012 FOLLOWING TISSUE DEBRIDEMENT AND REMOVAL OF INFECTED STRATTICE DEVICE (LIFECELL, INC.). AT THE TIME OF EXPLANTATION OF THE STRATTICE DEVICE, THE BREAST WALL WAS NOTED TO BE THIN. A DRAIN WAS PLACED PER NORMAL PROTOCOL FOR 10 DAYS. AT AN UNK DATE FOLLOWING DRAIN REMOVAL, POTENTIAL SEROMA FORMATION WAS OBSERVED. A DRAIN WAS RE-PLANTED IN A NON-OPERATIVE SETTING. AT AN UNK DATE FOLLOWING DRAIN PLACEMENT, PUS-LIKE EXUDATE WAS EXITING THE INCISION SITE. ON (B)(6) 2012, APPROX 3.8 OF THE ORIGINAL DEVICE WAS REMOVED ALONG WITH APPROX 100ML OF SEROUS FLUID. THE OPERATIVE DIAGNOSIS WAS ACUTE INFLAMMATION. CULTURES WERE REPORTEDLY NEGATIVE. MATRISTEM MICROMATRIX (ACELL, INC.) WAS SUBSEQUENTLY IMPLANTED IN THE SURGICAL SITE. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. DEVICE WAS USED IN AN OFF-LABEL PROCEDURE (BREAST RECONSTRUCTION). THE SAFETY AND EFFECTIVENESS OF THE DEVICE FOR THIS INDICATION HAVE NOT BEEN DEMONSTRATED AND THERE IS NO FDA CLEARANCE/APPROVAL FOR THIS APPLICATION. ACELL IS IN THE PROCESS OF CONDUCTING A COMPLAINT INVESTIGATION.

    Description of Event or Problem · 1

    ACELL PRODUCT WAS IMPLANTED INTO PT ON (B)(6) 2012. THIS PRODUCT WAS LATER EXPLANTED DURING A PROCEDURE ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRISTEM PLASTIC SURGERY MATRIX XS FTM, SURGICAL MESH FTM ACELL, INC. SM982-67

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R