BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 20, FIRM

    MDR report key: 14713533 · Received June 16, 2022

    Report

    Report Number
    1000306051-2022-00109
    Event Type
    Injury
    Date Received
    June 16, 2022
    Date of Event
    July 8, 2020
    Report Date
    July 6, 2022
    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 INTERNAL INVESTIGATION IS PENDING AND WILL BE REPORTED IN A FOLLOW UP REPORT ALONG WITH THE INVESTIGATION CONCLUSION.

    Additional Manufacturer Narrative · 0

    INTERNAL INVESTIGATION INTO STRATTICE LOT S10613 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 06/23/2022, OF THE 232 DEVICES RELEASED TO FINISHED GOODS FOR LOT S10613, 218 HAVE BEEN DISTRIBUTED WITH 132 REPORTED AS IMPLANTED. BASED ON OUR INTERNAL REVIEW WITH NO REMARKABLE FINDINGS, AND WITHOUT RELEVANT PATIENT FACTORS, A RELATIONSHIP BETWEEN THE STRATTICE AND THIS EVENT COULD NOT BE DETERMINED. NO FURTHER ACTIONS ARE REQUIRED AS A NONCONFORMANCE COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A LEGAL EVENT THAT A 48 YEAR OLD FEMALE PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT JANUARY 11, 2010. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE, 2020002- S10613-001 AFTER SURGERY, 10 YEARS LATER, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT JULY 8, 2020 AND WAS DIAGNOSED WITH A HUGE SYMPTOMATIC RECURRENT INCISIONAL HERNIA. THE PATIENT UNDERWENT A DIAGNOSTIC LAPAROSCOPY, LYSIS OF ADHESIONS AND OPEN INCISIONAL HERNIA REPAIR WITH PLACEMENT OF ADDITIONAL MESH. THE STRATTICE MESH WAS FOUND TO HAVE DISINTEGRATED.

    Description of Event or Problem · 0

    THIS IS FOLLOW UP#1 TO REPORT THE RESULTS OF THE INVESTIGATION INCLUDING THE CONCLUSION. AS REPORTED IN THE INITIAL: IT WAS REPORTED THROUGH A LEGAL EVENT THAT A 48 YEAR OLD FEMALE PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT JANUARY 11, 2010. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE, 2020002- S10613-001 AFTER SURGERY, 10 YEARS LATER, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT JULY 8, 2020 AND WAS DIAGNOSED WITH A HUGE SYMPTOMATIC RECURRENT INCISIONAL HERNIA. THE PATIENT UNDERWENT A DIAGNOSTIC LAPAROSCOPY, LYSIS OF ADHESIONS AND OPEN INCISIONAL HERNIA REPAIR WITH PLACEMENT OF ADDITIONAL MESH. THE STRATTICE MESH WAS FOUND TO HAVE DISINTEGRATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254651 STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 20, FIRM MESH, SURGICAL FTM S10613

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention NO INFORMATION