BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 10, FIRM

    MDR report key: 11998904 · Received June 15, 2021

    Report

    Report Number
    1000306051-2021-03006
    Event Type
    Injury
    Date Received
    June 15, 2021
    Date of Event
    February 3, 2014
    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 S11025 RESULTED IN NO REMARKABLE FINDINGS AND NO DEVIATIONS AND NO NONCONFROMANCES REVEALED. 305 DEVICES WERE RELEASED TO FINISHED GOODS. 187 REPORTED AS IMPLANTED 305 HAVE BEEN DISTRIBUTED. NO OTHER COMPLAINTS AGAINST. LOT S11025 WERE REVEALED. LOT S11025 WAS ASEPTICALLY PROCESSED, TERMINALLY STERILIZED AND MET ALL QC RELEASE CRITERIA.

    Description of Event or Problem · 1

    PATIENT REPRESENTATIVE REPORTED A FEMALE PATIENT HAD STRATTICE, 1010002, IMPLANTED ON (B)(6) 2012 FOR A VENTRAL HERNIA REPAIR. TWO YEARS LATER, (B)(6) 2014, PATIENT RETURNED TO HOSPITAL AND DIAGNOSED WITH INCISIONAL HERNIA. STRATTICE MESH REMOVED AT THAT TIME. LOT# S11025-135.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899403 STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 10, FIRM MESH, SURGICAL FTM S11025

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention