BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRISTEM SURGICAL MATRIX PSMX

    MDR report key: 2892196 · Received December 21, 2012

    Report

    Report Number
    3005920706-2012-00014
    Event Type
    Injury
    Date Received
    December 21, 2012
    Report Date
    November 27, 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 AND REVIEWED RELEVANT MEDICAL RECORDS. BASED ON ITS REVIEW, ACELL IS NOT AWARE OF ANY CLINICAL OR PATHOLOGICAL EVIDENCE INDICATING ITS PRODUCT WAS RELATED TO THE ADVERSE EVENT. THIS MDR IS BEING SUBMITTED OUT OF AN ABUNDANCE OF CAUTION. DEVICE WAS USED IN AN OFF LABEL PROCEDURE. THE SAFETY AND EFFECTIVENESS OF THE USE OF THE DEVICE AS AN ADHESION BARRIER HAVE NOT BEEN DEMONSTRATED AND THERE IS NO FDA APPROVAL FOR THIS APPLICATION. ACELL IS IN THE PROCESS OF CONTINUING ITS COMPLAINT INVESTIGATION.

    Description of Event or Problem · 1

    MORBIDLY OBESE PATIENT WAS IMPLANTED WITH MATRISTEM SURGICAL MATRIX PSMX AS AN ADHESION BARRIER BETWEEN THE LIVER AND STOMACH DURING A LAPAROSCOPIC GASTRIC SLEEVE PROCEDURE ON (B)(6) 2012. AT APPROXIMATELY ONE WEEK POST-OP, THE PHYSICIAN NOTED THAT FLUID HAD ACCUMULATED IN THE ABDOMEN AND ACCORDING TO THE SALES REP, ¿THE LIVER STARTED TO CONTRACT¿. THE PATIENT WAS TAKEN BACK TO SURGERY TO EVACUATE FLUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRISTEM SURGICAL MATRIX PSMX FTM, SURGICAL MESH FTM ACELL INC. SM2305-61

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R CRESTOR| LEXAPRO| BENICAR HCT| METFORMIN HC1| ZANTAC| ATENONOL