BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRISTEM SURGICAL MATRIX PSMT

    MDR report key: 3878079 · Received June 6, 2014

    Report

    Report Number
    3005920706-2014-00005
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 7, 2014
    Manufacturer
    ACELL INC.
    Product Code
    FTM
    PMA / PMN Number
    K041140
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY CONDUCTED ON DISCOVERY. NO SUBSTANTIAL DEVIATION WAS IDENTIFIED AND ALL RECORDS PURPORT THE PRODUCT WAS MANUFACTURED AND DISTRIBUTED STERILE IN COMPLIANCE WITH FDA, STATE, LOCAL AND MANUFACTURER OPERATING PROCEDURES. THERE WAS NO REPORT OF DEVICE FAILURE AT THE TIME OF SURGERY. ALL ACEL DEVICES ARE SUPPLIED STERILE AND THERE IS NO INDICATION THAT THE PT INFECTION WAS RELATED TO THE DEVICE.

    Description of Event or Problem · 1

    MATRISTEM SURGICAL MESH DEVICE WAS UTILIZED IN A COLOSTOMY REVERSAL WITH COLON RESECTION PROCEDURE ON (B)(6) 2014. THE PT WAS ADEQUATELY PROGRESSING AND 5 DAYS POST-OP, DEVELOPED SYMPTOMS OF NAUSEA WITH ELEVATED WHITE COUNT THAT WAS TREATED WITH ANTIBIOTICS. AN ABDOMINAL IMAGE WAS OBTAINED SEVERAL WEEKS LATER AND REVEALED AN ABSCESS. THE PT UNDERWENT A SUBSEQUENT PROCEDURE ON (B)(6) 2014 AND THE DEVICE WAS PARTIALLY REMOVED DURING DEBRIDEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332415 MATRISTEM SURGICAL MATRIX PSMT FTM, SURGICAL MESH FTM ACELL INC. OM1060-804

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R