BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 16, FIRM

    MDR report key: 12034776 · Received June 21, 2021

    Report

    Report Number
    1000306051-2021-03015
    Event Type
    Injury
    Date Received
    June 21, 2021
    Date of Event
    September 28, 2016
    Product Code
    FTM
    UDI-DI
    00818410010119
    PMA / PMN Number
    K070560
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A INVESTIGATION INTO LOT SP100247 RESULTED IN NO REMARKABLE FINDINGS AND NO DEVIATIONS AND ONE UNRELATED NONCONFORMANCE REVEALED. (B)(4) DEVICES RELEASED TO FINISHED GOODS FOR LOT SP100247, (B)(4) HAVE BEEN DISTRIBUTED. OF THE (B)(4) DISTRIBUTED, (B)(4) HAVE BEEN REPORTED AS IMPLANTED. NO OTHER COMPLAINTS AGAINST LOT SP100247 WERE REVEALED. LOT SP100247 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) 2015 FOR A HERNIA REPAIR. PATIENT RETURNED TO HOSPITAL ON (B)(6) 2016 AND DIAGNOSED WITH INCISIONAL HERNIA. STRATTICE MESH REMOVED AT THAT TIME. LOT KNOWN SP100247

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931728 STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 16, FIRM MESH, SURGICAL FTM SP100247 00818410010119

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention