BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 30, FIRM

    MDR report key: 16279929 · Received February 1, 2023

    Report

    Report Number
    1000306051-2023-00004
    Event Type
    Injury
    Date Received
    February 1, 2023
    Date of Event
    March 27, 2014
    Report Date
    March 27, 2024
    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 S10989 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 09 FEB 2023, ALL OF THE 117 DEVICES RELEASED TO FINISHED GOODS FOR LOT S10989 HAVE BEEN DISTRIBUTED WITH 71 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. AS REPORTED IN THE INITIAL: 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.

    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 55 YEAR OLD FEMALE PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6), 2012. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH. THE RECORDS INDICATE THIS IS A LIFECELL ¿ STRATTICE RECONSTRUCTIVE TISSUE MATRIX (TRM) LOT # S10989-094 REF # 2030002 MESH. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6), 2014, FOR A REVISION SURGERY AND EXPLANTATION OF THE STRATTICE MESH. DURING MARY AND APRIL 2014, THE PATIENT UNDERWENT MULTIPLE SURGERIES INCLUDING MULTIPLE INCISION AND DEBRIDEMENTS, DRAINAGE OF SEROMAS AND ABSCESSES, AND WOUND EXPLORATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A LEGAL EVENT THAT A 55 YEAR OLD FEMALE PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2012. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH. THE RECORDS INDICATE THIS IS A LIFECELL ¿ STRATTICE RECONSTRUCTIVE TISSUE MATRIX (TRM) LOT # S10989-094 REF # 2030002 MESH. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2014, FOR A REVISION SURGERY AND EXPLANTATION OF THE STRATTICE MESH. DURING MARY AND (B)(6) 2014, THE PATIENT UNDERWENT MULTIPLE SURGERIES INCLUDING MULTIPLE INCISION AND DEBRIDEMENTS, DRAINAGE OF SEROMAS AND ABSCESSES, AND WOUND EXPLORATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A LEGAL EVENT THAT A 55 YEAR OLD FEMALE PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2012. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH. THE RECORDS INDICATE THIS IS A LIFECELL ¿ STRATTICE RECONSTRUCTIVE TISSUE MATRIX (TRM) LOT # S10989-094 REF # (B)(4) MESH. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2014, FOR A REVISION SURGERY AND EXPLANTATION OF THE STRATTICE MESH. DURING (B)(6) 2014, THE PATIENT UNDERWENT MULTIPLE SURGERIES INCLUDING MULTIPLE INCISION AND DEBRIDEMENTS, DRAINAGE OF SEROMAS AND ABSCESSES, AND WOUND EXPLORATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1301320 STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 30, FIRM MESH, SURGICAL FTM LIFECELL S10989

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention