BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 30, FIRM

    MDR report key: 14457481 · Received May 20, 2022

    Report

    Report Number
    1000306051-2022-00095
    Event Type
    Injury
    Date Received
    May 20, 2022
    Date of Event
    March 11, 2021
    Report Date
    May 19, 2022
    Product Code
    FTM
    UDI-DI
    00818410010393
    PMA / PMN Number
    K070560
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL INVESTIGATION INTO STRATTICE LOT SP100368 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 DEVIATIONS OR RELATED NON-CONFORMANCE'S REVEALED DURING PROCESSING. THE LOT WAS TERMINALLY STERILIZED WITHIN THE PROCESS PARAMETERS AND MET ALL QC RELEASE CRITERIA. (B)(4). BASED ON OUR INTERNAL REVIEW WITH NO REMARKABLE FINDINGS, A RELATIONSHIP BETWEEN THE STRATTICE AND THIS EVENT COULD NOT BE DETERMINED. NO FURTHER ACTIONS ARE REQUIRED AS A NONCONFORMANCE COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A LEGAL EVENT THAT A (B)(6) MALE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2016. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE RECONSTRUCTIVE TISSUE MATRIX ITEM 2030002, LOT SP100368 MESH IN HIM. AFTER SURGERY, 5 YEARS LATER, THE PATIENT HAD A REVISION SURGERY ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1520194 STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 30, FIRM MESH, SURGICAL FTM SP100368 00818410010393

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention NO INFORMATION REPORTED