BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 30 X 30CM, FIRM

    MDR report key: 13588029 · Received February 23, 2022

    Report

    Report Number
    1000306051-2022-00016
    Event Type
    Injury
    Date Received
    February 23, 2022
    Date of Event
    June 23, 2016
    Report Date
    February 23, 2022
    Product Code
    FTM
    UDI-DI
    00818410011796
    PMA / PMN Number
    K070560
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS LEGAL EVENT IS BEING REPORTED AS SERIOUS INJURY DUE TO THE REPORTED RECURRENCE WITH SURGICAL INTERVENTION. INTERNAL INVESTIGATION INTO STRATTICE LOT SP100244 INCLUDED A REVIEW OF THE REPORTED INFORMATION, REVIEW OF THE DEVICE HISTORY RECORDS, AND A REVIEW OF THE COMPLAINT HISTORY RECORDS WITH NO REMARKABLE FINDINGS, INCLUDING NO OTHER COMPLAINTS REPORTED AGAINST THE LOT AND NO DEVIATIONS OR NON-CONFORMANCES REVEALED DURING PROCESSING. THE LOT WAS ASEPTICALLY PROCESSED, TERMINALLY STERILIZED WITHIN THE PROCESS PARAMETERS AND MET ALL QC RELEASE CRITERIA. TO DATE, OF THE (B)(4) DEVICES RELEASED TO FINISHED GOODS, (B)(4) HAVE BEEN DISTRIBUTED WITH (B)(4) DEVICES REPORTED AS IMPLANTED. DUE TO THE LEGAL PROCESS, IF ADDITIONAL INFORMATION IS MADE AVAILABLE DURING LEGAL PROCEEDINGS, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A LEGAL EVENT THAT A (B)(6) WOMEN UNDERWENT HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2015. THE SURGEON PERFORMED THE RECURRENT INCARCERATED MIDLINE AND INCISIONAL HERNIA REPAIR AT THE MEDICAL CENTER (B)(6). DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH IN THE PATIENT. THE RECORDS INDICATE IT WAS STRATTICE MESH ITEM 3030002, LOT SP100244-319. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2016 FOR A MESH EXPLANT SURGERY AT THE MEDICAL CENTER (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2127580 STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 30 X 30CM, FIRM MESH, SURGICAL FTM SP100244 00818410011796

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention NO INFORMATION REPORTED