BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 8 X 8, FIRM

    MDR report key: 16461561 · Received March 1, 2023

    Report

    Report Number
    1000306051-2023-00052
    Event Type
    Injury
    Date Received
    March 1, 2023
    Date of Event
    March 21, 2014
    Report Date
    March 17, 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

    THIS LEGAL EVENT IS BEING REPORTED AS SERIOUS INJURY DUE TO THE REPORTED RECURRENCE WITH SURGICAL INTERVENTION. THE LOT ASSOCIATED WITH THIS EVENT WAS NOT REPORTED AND REMAINS UNKNOWN; THEREFORE AN INTERNAL INVESTIGATION INTO THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. NO STRATTICE DEVICES WERE RETURNED FOR EVALUATION. BASED ON THE LIMITED INFORMATION, INCLUDING NO IDENTIFICATION OF THE LOT NUMBER, AND WITHOUT RELEVANT PATIENT FACTORS, A RELATIONSHIP BETWEEN THE EVENT AND THE STRATTICE 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

    INTERNAL INVESTIGATION INTO STRATTICE LOT S11222 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 MARCH 2023, OF THE (B)(4) DEVICES RELEASED TO FINISHED GOODS FOR LOT S11222, 192 HAVE BEEN DISTRIBUTED WITH 12 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 LOT ASSOCIATED WITH THIS EVENT WAS NOT REPORTED AND REMAINS UNKNOWN; THEREFORE AN INTERNAL INVESTIGATION INTO THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. NO STRATTICE DEVICES WERE RETURNED FOR EVALUATION. BASED ON THE LIMITED INFORMATION, INCLUDING NO IDENTIFICATION OF THE LOT NUMBER, AND WITHOUT RELEVANT PATIENT FACTORS, A RELATIONSHIP BETWEEN THE EVENT AND THE STRATTICE 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 PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2013 AND AGAIN ON (B)(6) 2013. 76. DURING HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH DURING BOTH THE (B)(6) 2013 SURGERIES. THE RECORDS INDICATE THE DEVICE WAS A STRATTICE MESH. AFTER SURGERY, PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2014, FOR A REVISION SURGERY, RESULTING IN PLAINTIFF¿S TWO STRATTICE MESHES BEING REMOVED. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 1000306051-2023-00051 (ALLERGAN COMPLAINT # (B)(4) ). THIS MDR IS BEING SUBMITTED FOR THE SECOND DEVICE IMPLANTED ON (B)(6) 2013.

    Description of Event or Problem · 0

    ON 03/15/2023, PMQA RECEIVED NOTIFICATION FROM LEGAL THAT THE LOT ASSOCIATED WITH THIS EVENT WAS FOUND THROUGH DISCOVERY AND IS S11222-157 (B)(6) 2013 IMPLANT). NO OTHER INFORMATION WAS REPORTED. AS REPORTED IN THE INITIAL: IT WAS REPORTED THROUGH A LEGAL EVENT THAT A PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2013 AND AGAIN ON (B)(6) 2013. 76. DURING HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH DURING BOTH THE FEBRUARY AND (B)(6) 2013 SURGERIES. THE RECORDS INDICATE THE DEVICE WAS A STRATTICE MESH. AFTER SURGERY, PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2014, FOR A REVISION SURGERY, RESULTING IN PLAINTIFF¿S TWO STRATTICE MESHES BEING REMOVED. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 1000306051-2023-00051 (ALLERGAN COMPLAINT #PR (B)(6). THIS MDR IS BEING SUBMITTED FOR THE SECOND DEVICE IMPLANTED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1143121 STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 8 X 8, FIRM MESH, SURGICAL FTM LIFECELL S11222

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Required Intervention NO INFORMATION REPORTED.