BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STRATTICE

    MDR report key: 17198191 · Received June 26, 2023

    Report

    Report Number
    1000306051-2023-00138
    Event Type
    Injury
    Date Received
    June 26, 2023
    Report Date
    August 21, 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

    THE LOT ASSOCIATED WITH THIS EVENT REMAINS UNKNOWN. THE CONCLUSION REMAINS THE SAME. 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 Manufacturer Narrative · 0

    THIS LEGAL EVENT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION 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 FOLLOW UP#1 TO REPORT ON 26/JUL/2023, 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 REPAIR OF VENTRAL HERNIA AND WAS IMPLANTED WITH STRATTICE DEVICE LOT SP100622-52, REF# 2030002 ON (B)(6) 2018. THE PATIENT UNDERWENT A "REPAIR OF RECURRENT VENTRAL HERNIA WITH LYSIS OF ADHESIONS AND REMOVAL OF PREVIOUSLY PLACED MESH" ON (B)(6) 2021. ADDITIONAL INFORMATION STATES "THE FAILURE OF THE MESH CAUSED CHRONIC PAIN, ADHESIONS, AND A HERNIA RECURRENCE WHICH REQUIRED AN ADDITIONAL SURGICAL PROCEDURE WHICH THE STRATTICE MESH WAS REMOVED. THE PATIENT CONTINUES TO EXPERIENCE SYMPTOMS, INCLUDING, BUT NOT LIMITED TO, PAIN AND DISCOMFORT AS A RESULT OF THE RECURRENCE CAUSED BY THE FAILURE OF HIS STRATTICE HERNIA MESH IMPLANT." THE FORM LISTS THE PATIENT WAS TREATED FOR ¿ADHESIONS¿, "HERNIA RECURRENCE", "SEVERE PAIN", AND ¿ALL OTHER CONDITIONS IDENTIFIED¿ WITH APPROXIMATE DATES OF TREATMENT IN 2021. THE PPF FORM ALSO INDICATES THE PATIENT WAS IMPLANTED WITH ANOTHER NON-ABBVIE DEVICE, BARD ON (B)(6)2021 AND NO "REVISION OR REMOVAL" WAS REPORTED. ALTHOUGH A LOT NUMBER WAS REPORTED, "SP100622-52" IS NOT A VALID LOT NUMBER AND WILL REMAIN UNKNOWN. NO OTHER INFORMATION WAS PROVIDED. AS REPORTED IN THE INITIAL: LIMITED INFORMATION WAS REPORTED THROUGH A LEGAL EVENT THAT A PATIENT WAS IMPLANTED WITH STRATTICE FIRM ON (B)(6), 2018. 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 FIRM ON (B)(6) 2018. 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
    1541135 UNKNOWN STRATTICE MESH, SURGICAL FTM LIFECELL NI

    Patients

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