BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 30 X 30CM, FIRM

    MDR report key: 15158083 · Received August 3, 2022

    Report

    Report Number
    1000306051-2022-00126
    Event Type
    Injury
    Date Received
    August 3, 2022
    Date of Event
    January 29, 2021
    Report Date
    August 3, 2022
    Product Code
    FTM
    UDI-DI
    00818410011796
    PMA / PMN Number
    K070560
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS LEGAL EVENT IS BEING REPORTED AS SERIOUS INJURY DUE TO THE REPORTED RECURRENCE AND FAILURE TO INTEGRATE WITH SURGICAL INTERVENTION. INTERNAL INVESTIGATION INTO STRATTICE LOT SP100503 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-CONFORMANCES REVEALED DURING PROCESSING. THE LOT WAS TERMINALLY STERILIZED WITHIN THE PROCESS PARAMETERS AND MET ALL QC RELEASE CRITERIA. AS OF (B)(6) 2022, OF THE 235 DEVICES RELEASED TO FINISHED GOODS FOR LOT SP100503, 229 HAVE BEEN DISTRIBUTED WITH 131 REPORTED AS IMPLANTED. BASED ON OUR INTERNAL INVESTIGATION WITH NO REMARKABLE FINDINGS, AND WITHOUT RELEVANT PATIENT FACTORS, A RELATIONSHIP BETWEEN THE STRATTICE AND THIS EVENT COULD NOT BE DETERMINED. 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 69 YEAR OLD FEMALE PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2017. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH; CATALOG NUMBER IS 3030002 AND LOT NUMBER IS SP100503-242. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2021, REPORTING SHARP AND CUTTING PAIN, NAUSEA, AND HAVING TO CONSISTENTLY WEAR ABDOMINAL BINDERS. ON OR ABOUT (B)(6) 2021, THE PATIENT WAS DIAGNOSED WITH ABDOMINAL PAIN AND A RECURRENT HERNIA AND UNDERWENT AN EXPLORATORY LAPAROTOMY, EXCISION OF OLD MESH AND ABDOMEN CLOSURE. UPON SURGICAL DISSECTION, THE SURGEON NOTED FAILURE OF THE MESH TO INCORPORATE INTO THE TISSUE. THE MESH WAS FOUND ADHERED TO A FEW SPOTS IN THE LEFT UPPER ABDOMEN. THE MESH WAS FOLDED MULTIPLE TIMES AND WRINKLED CLOSE TO THE AREA WHERE SHE WAS EXPERIENCING SEVERE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1570211 STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 30 X 30CM, FIRM MESH, SURGICAL FTM SP100503 00818410011796

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention NO INFORMATION