BEUDAMED
    FDA Adverse Event Other Summary report: N

    MATRISTEM SURGICAL MATRIX PSM

    MDR report key: 2933144 · Received January 25, 2013

    Report

    Report Number
    3005920706-2013-00005
    Event Type
    Other
    Date Received
    January 25, 2013
    Date of Event
    December 28, 2012
    Report Date
    December 28, 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

    BASED ON IT'S 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.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH MATRISTEM SURGICAL MATRIX PSM DURING A LAPAROSCOPIC GASTRIC SLEEVE PROCEDURE ON (B)(6) 2012. AT A PLANNED FOLLOW-UP SURGERY ON (B)(6) 2012, THE PHYSICIAN NOTED THE PRESENCE OF YELLOWISH FLUID BETWEEN THE DEVICE LAYERS AND ADHESION OF THE DEVICE TO THE LIVER AND STOMACH. THE PORTION OF DEVICE ADHERED TO THE STOMACH WAS REMOVED BY PHYSICIAN, AND THE SURGERY WAS FINISHED AS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36132 MATRISTEM SURGICAL MATRIX PSM FTM ACELL INC. SM425-31

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention