BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 10, FIRM

    MDR report key: 13999120 · Received April 4, 2022

    Report

    Report Number
    1000306051-2022-00044
    Event Type
    Injury
    Date Received
    April 4, 2022
    Date of Event
    February 12, 2019
    Report Date
    April 4, 2022
    Product Code
    FTM
    UDI-DI
    00818410010096
    PMA / PMN Number
    K070560
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS LEGAL EVENT IS BEING REPORTED AS SERIOUS INJURY DUE TO THE REPORTED COMPLICATIONS WITH SURGICAL INTERVENTION. INTERNAL INVESTIGATION INTO STRATTICE LOT SP100589 INCLUDED A REVIEW OF THE REPORTED INFORMATION, REVIEW OF THE DEVICE HISTORY RECORDS, AND A REVIEW OF THE COMPLAINT HISTORY RECORDS. THE INVESTIGATION RESULTED IN NO REMARKABLE FINDINGS, INCLUDING NO OTHER COMPLAINTS REPORTED AGAINST THE LOT AND NO RELATED DEVIATIONS OR NON-CONFORMANCES REVEALED DURING MANUFACTURING. THE LOT WAS TERMINALLY STERILIZED WITHIN THE PROCESS PARAMETERS AND MET ALL QC RELEASE CRITERIA. AS OF 4/4/22, OF THE 261 DEVICES RELEASED TO FINISHED GOODS, 231 HAVE BEEN DISTRIBUTED WITH 16 DEVICES REPORTED AS IMPLANTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A LEGAL EVENT THAT A (B)(6) MALE PATIENT UNDERWENT AN INCARCERATED UMBILICAL HERNIA REPAIR SURGERY ON (B)(6) 2018 AT GRAND STRAND MEDICAL CENTER. DURING THE SURGERY, THE SURGEON IMPLANTED STRATTICE MESH LOT SP100589-246, ITEM 1010002. ON (B)(6), 2019, THE PATIENT UNDERWENT SURGERY IN WHICH THE SECOND SURGEON: LYSED ADHESIONS BETWEEN THE MESH, OMENTUM, AND THE LOOP OF THE SMALL BOWEL, AND REMOVED THE MESH IN ITS ENTIRETY, RESECTED A PORTION OF THE SMALL BOWEL DUE TO CONCERN OF POSSIBLE FISTULA FORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1280469 STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 10, FIRM MESH, SURGICAL FTM SP100589 00818410010096

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Required Intervention NO INFORMATION REPORTED