BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 25, FIRM

    MDR report key: 19287275 · Received May 10, 2024

    Report

    Report Number
    1000306051-2024-00124
    Event Type
    Injury
    Date Received
    May 10, 2024
    Date of Event
    February 17, 2011
    Report Date
    August 13, 2024
    Manufacturer
    BRANCHBURG
    Product Code
    FTM
    UDI-DI
    00818410010157
    PMA / PMN Number
    K070560
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL AND/OR CORRECTED DATA: A2, B3, B5, D4, D6B, H6.

    Additional Manufacturer Narrative · 0

    THE LOT ASSOCIATED WITH THIS EVENT WAS NOT REPORTED AND REMAINS UNKNOWN; THEREFORE A REVIEW INTO THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. NO STRATTICE DEVICES WERE RETURNED FOR EVALUATION. BASED ON THE LIMITED INFORMATION, 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 FOLLOW UP#1 TO REPORT ON (B)(6) 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 ¿VENTRAL HERNIA¿ SURGERY AND WAS IMPLANTED WITH A STRATTICE DEVICE LOT 810667-302 AND CATALOG 2025002 ON (B)(6) 2010. THE PATIENT UNDERWENT A ¿REMOVAL OF MESH + INJURY (ADHESIONS, PAIN) TO REPAIR RECURRENT INCISIONAL HERNIA¿ ON (B)(6) 2011. THE FORM LISTS THE CONDITIONS THAT WAS TREATED WAS ¿HERNIA¿ IN 2010 AND 2011. THE PPF FORM ALSO INDICATES THAT THE PATIENT WAS IMPLANTED WITH A NON-ABBVIE DEVICE, ¿BARD/DAVOL: SEPRAMESH IP (LOT: UNKNOWN),¿ ON (B)(6) 2011. THE FORM INDICATES THAT THE DEVICE WAS REMOVED ON (B)(6) 2022 DUE TO ¿ADHESIONS, FISTULA, INFECTION, MESH EXPOSED, AND WOUND VAC TO REPAIR INCISIONAL HERNIA.¿ THE PATIENT RECEIVED TREATMENT FOR ¿HERNIA¿ RELATED TO THIS DEVICE IN 2011 AND 2022. AS REPORTED IN THE INITIAL: LIMITED INFORMATION WAS REPORTED THROUGH A LEGAL EVENT THAT A PATIENT WAS IMPLANTED WITH STRATTICE ON (B)(6) 2010. 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) 2010. 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
    982661 STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 25, FIRM MESH, SURGICAL FTM BRANCHBURG NI 00818410010157

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention