BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 20, FIRM

    MDR report key: 11991263 · Received June 14, 2021

    Report

    Report Number
    1000306051-2021-03005
    Event Type
    Injury
    Date Received
    June 14, 2021
    Date of Event
    January 18, 2010
    Manufacturer
    LIFECELL
    Product Code
    FTM
    PMA / PMN Number
    K070560
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    QA INVESTIGATION INTO LOT S10546 RESULTED IN NO REMARKABLE FINDINGS AND NO DEVIATIONS AND NO NONCONFROMANCES REVEALED. (B)(4) DEVICES WERE RELEASED TO FINISHED GOODS.(B)(4) REPORTED AS IMPLANTED (B)(4) HAVE BEEN DISTRIBUTED. NO OTHER COMPLAINTS AGAINST. LOT S10546 WERE REVEALED. LOT S10546 WAS ASEPTICALLY PROCESSED, TERMINALLY STERILIZED AND MET ALL QC RELEASE CRITERIA.

    Description of Event or Problem · 1

    PATIENT REPRESENTATIVE REPORTS A (B)(6) YO MALE PATIENT HAD A HERNIA REPAIR WITH STRATTICE ON (B)(6) 2009. ON (B)(6) 2010, A REMOVAL OF THE MESH WAS REQUIRED AND A REPAIR OF THE INCISIONAL HERNIA. PARTIAL KNOWN LOT S10546 CATALOG 2020002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888757 STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 20, FIRM MESH, SURGICAL FTM LIFECELL S10546

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention