BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 20, FIRM

    MDR report key: 17085704 · Received June 8, 2023

    Report

    Report Number
    1000306051-2023-00123
    Event Type
    Injury
    Date Received
    June 8, 2023
    Date of Event
    January 27, 2011
    Report Date
    June 20, 2023
    Manufacturer
    LIFECELL
    Product Code
    FTM
    PMA / PMN Number
    K070560
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL AND/OR CORRECTED DATA: B5, D4, G6, H2, H6 INTERNAL INVESTIGATION INTO STRATTICE LOT S10560 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 15 JUNE 2023, OF THE (B)(4)DEVICES RELEASED TO FINISHED GOODS FOR LOT S10560, 110 HAVE BEEN DISTRIBUTED. OF THE 110 DISTRIBUTED, 76 HAVE BEEN 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.

    Additional Manufacturer Narrative · 0

    THIS LEGAL EVENT IS BEING REPORTED AS SERIOUS INJURY DUE TO THE REPORTED RECURRENCE WITH SURGICAL INTERVENTION. THE INTERNAL INVESTIGATION IS PENDING AND WILL BE REPORTED IN A FOLLOW UP REPORT ALONG WITH THE INVESTIGATION CONCLUSION.

    Description of Event or Problem · 0

    THIS IS FOLLOW UP# 1 TO REPORT THE RESULTS FROM THE INTERNAL INVESTIGATION AND THE CONCLUSION. THE AWARE DATE IS BASED ON WHEN THE BATCH RECORD REVIEW WAS COMPLETED. AS REPORTED IN THE INITIAL: IT WAS REPORTED THROUGH A LEGAL EVENT THAT A 56 YEAR OLD PATIENT HAD HERNIA REPAIR SURGERY ON (B)(6) 2009. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH; S10560-023, 2020002. AFTER SURGERY, THE PATIENT HAD REVISION SURGERIES ON (B)(6) 2011, AND (B)(6) 2021. NO OTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A LEGAL EVENT THAT A 56 YEAR OLD PATIENT HAD HERNIA REPAIR SURGERY ON (B)(6) 2009. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH; S10560-023, 2020002. AFTER SURGERY, THE PATIENT HAD REVISION SURGERIES ON (B)(6) 2011, AND (B)(6) 2021. NO OTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1274761 STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 20, FIRM MESH, SURGICAL FTM LIFECELL S10560

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention NO INFORMATION REPORTED.