BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 16, FIRM

    MDR report key: 17685869 · Received September 5, 2023

    Report

    Report Number
    1000306051-2023-00201
    Event Type
    Injury
    Date Received
    September 5, 2023
    Date of Event
    August 1, 2016
    Report Date
    June 10, 2024
    Manufacturer
    LIFECELL
    Product Code
    FTM
    PMA / PMN Number
    K070560
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD FOR STRATTICE LOT: (B)(6) HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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 AND/OR CORRECTED DATA: A2, B3, B5, D4, H4, H6.

    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.

    Description of Event or Problem · 0

    THIS IS ON 30/MAY/2024, PMQA RECEIVED NOTIFICATION FROM LEGAL THAT THE PLAINTIFF PROFILE FORM WAS RECEIVED ASSOCIATED WITH THIS EVENT. AS PER THE PPF FORM, THE PATIENT UNDERWENT A ¿RECURRENT LEFT INGUINAL HERNIA¿ SURGERY AND WAS IMPLANTED WITH STRATTICE DEVICE ON (B)(6) 2011. THE PATIENT UNDERWENT A ¿LYSIS OF ADHESIONS; REPAIR OF BLADDER; REVISION OF MESH WITH ADDITIONAL MESH TO REPAIR RECURRENT INGUINAL HERNIA¿ ON (B)(6) 2016. AS PER THE PPF FORM, THE PATIENT CLAIMS THE IMPLANTATION AND FAILURE OF THE MESH CAUSED ¿RECURRENCE, ADHESIONS.¿ THE FORM LISTS THE CONDITIONS THAT WERE TREATED WERE ¿RECURRENT INGUINAL HERNIA; ADHESIONS¿ ON OR ABOUT (B)(6) 2016. THE PPF FORM ALSO INDICATES THAT THE PATIENT WAS IMPLANTED WITH A NON-ABBVIE DEVICE, ¿J&J ETHICON PROLENE ¿ NONSPECIFIC,¿ ON (B)(6) 2005. THE FORM INDICATES THAT THE DEVICE WAS NOT REMOVED OR REVISED. THE PPF FORM INDICATES THAT THE PATIENT WAS IMPLANTED WITH ANOTHER NON-ABBVIE DEVICE, ¿J&J ETHICON PROLENE ¿ NONSPECIFIC¿ ON (B)(6) 2016. THE FORM INDICATES THAT THE DEVICE WAS REMOVED OR REVISED ON (B)(6) 2008 DUE TO ¿RECURRENCE.¿ THE PPF FORM INDICATES THAT THE PATIENT WAS IMPLANTED WITH A THIRD NON-ABBVIE DEVICE, ¿COVIDIEN/MEDTRONIC PARIETEX FLAT SHEET¿ ON (B)(6) 2008. THE FORM INDICATES THAT THE DEVICE WAS REMOVED OR REVISED ON (B)(6) 2008 DUE TO ¿RECURRENCE, EROSION INTO BLADDER, ADHESIONS.¿ THE PPF FORM INDICATES THAT THE PATIENT WAS IMPLANTED WITH A FOURTH NON-ABBVIE DEVICE, ¿ATRIUM C-QUR;¿ ON (B)(6) 2009. THE FORM INDICATES THAT THE DEVICE WAS REMOVED OR REVISED ON (B)(6) 2011 DUE TO ¿RECURRENCE.¿ THE PPF FORM INDICATES THAT THE PATIENT WAS IMPLANTED WITH A FIFTH NON-ABBVIE DEVICE, ¿ATRIUM C-QUR; LOT UNKNOWN¿ ON (B)(6) 2009. THE FORM INDICATES THAT THE DEVICE WAS NOT REMOVED OR REVISED. THE PPF FORM INDICATES THAT THE PATIENT WAS IMPLANTED WITH A SIXTH NON-ABBVIE DEVICE, ¿COVIDIEN/MEDTRONIC PARIETEX OPTIMIZED COMPOSITE MESH¿ ON (B)(6) 2016. THE FORM INDICATES THAT THE DEVICE WAS NOT 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) 2011. 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

    LIMITED INFORMATION WAS REPORTED THROUGH A LEGAL EVENT THAT A PATIENT WAS IMPLANTED WITH STRATTICE ON (B)(6) 2011. 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
    1560979 STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 16, FIRM MESH, SURGICAL FTM LIFECELL S10912

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Required Intervention NO INFORMATION REPORTED