BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 6 X 16, FIRM

    MDR report key: 18415610 · Received December 28, 2023

    Report

    Report Number
    1000306051-2023-10025
    Event Type
    Injury
    Date Received
    December 28, 2023
    Date of Event
    July 6, 2017
    Report Date
    February 26, 2024
    Manufacturer
    BRANCHBURG
    Product Code
    FTM
    PMA / PMN Number
    K070560
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    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

    THIS LEGAL EVENT IS BEING REPORTED AS SERIOUS INJURY DUE TO THE REPORTED RECURRENCE WITH SURGICAL INTERVENTION. A REVIEW OF THE DEVICE HISTORY RECORD FOR STRATTICE LOT: S11072 HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. NO STRATTICE DEVICES WERE RETURNED FOR EVALUATION. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING. 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, CHANGED, AND/OR CORRECTED DATA.

    Description of Event or Problem · 0

    LIMITED INFORMATION WAS REPORTED THROUGH A LEGAL EVENT THAT A PATIENT WAS IMPLANTED WITH STRATTICE ON (B)(6) 2012. THE FORM ALSO INDICATES THAT ON AN UNSPECIFIED DATE, THE STRATTICE IMPLANT HAD BEEN ¿REMOVED OR REVISED¿. NO INFORMATION WAS PROVIDED ON THE INDICATION FOR THE INITIAL SURGERY OR THE REASON FOR THE REMOVAL OR REVISION.

    Description of Event or Problem · 0

    THIS IS FOLLOW UP#1 TO REPORT ON 25/JAN/2024, MQA RECEIVED NOTIFICATION FROM LEGAL THAT THE PLAINTIFF PROFILE FORM WAS RECEIVED ASSOCIATED WITH THIS EVENT. AS PER THE PPF FORM, THE PATIENT UNDERWENT AN ¿INCARCERATED VENTRAL HERNIA¿ SURGERY AND WAS IMPLANTED WITH STRATTICE DEVICE LOT: S11072-123 ON (B)(6) 2012. THE PATIENT UNDERWENT A ¿RECURRENT INCISIONAL HERNIA REPAIR WITH MESH¿ ON (B)(6) 2017. AS PER THE PPF FORM, THE PATIENT CLAIMS THE IMPLANTATION AND FAILURE OF THE MESH CAUSED ¿PAIN, RECURRENCE, AND INTERVENTION SURGERY.¿ THE FORM LISTS THE CONDITIONS THAT WERE TREATED WERE ¿PAIN, RECURRENCE, AND INTERVENTION SURGERY¿ WITH APPROXIMATE DATE OF TREATMENT ON (B)(6) 2017. THE PPF FORM ALSO INDICATES THE PATIENT WAS IMPLANTED WITH A NON-ABBVIE DEVICE, " ETHICON / J&J PHYSIOMESH; LOT#: OPHY1215¿ ON (B)(6) 2017. THE FORM INDICATES THAT THIS DEVICE HAS NOT BEEN REMOVED OR REVISED. AS REPORTED IN THE INITIAL: LIMITED INFORMATION WAS REPORTED THROUGH A LEGAL EVENT THAT A PATIENT WAS IMPLANTED WITH STRATTICE ON (B)(6) 2012. THE FORM ALSO INDICATES THAT ON AN UNSPECIFIED DATE, THE STRATTICE IMPLANT HAD BEEN ¿REMOVED OR REVISED¿. NO INFORMATION WAS PROVIDED ON THE INDICATION FOR THE INITIAL SURGERY OR THE REASON FOR THE REMOVAL OR REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1400416 STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 6 X 16, FIRM MESH, SURGICAL FTM BRANCHBURG S11072

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male Required Intervention