BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 16, FIRM

    MDR report key: 15710191 · Received November 1, 2022

    Report

    Report Number
    1000306051-2022-00178
    Event Type
    Injury
    Date Received
    November 1, 2022
    Date of Event
    October 7, 2011
    Report Date
    November 4, 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

    THIS LEGAL EVENT IS BEING REPORTED AS SERIOUS INJURY DUE TO THE REPORTED RECURRENCE WITH SURGICAL INTERVENTION. THE LOT ASSOCIATED WITH THIS EVENT IS S10645-118; HOWEVER, THE INTERNAL INVESTIGATION IS PENDING AND WILL BE REPORTED IN A FOLLOW UP REPORT ALONG WITH THE INVESTIGATION CONCLUSION.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP IS TO REPORT THE RESULTS FROM THE INTERNAL INVESTIGATION AND CONCLUSION. INTERNAL INVESTIGATION INTO STRATTICE LOT S10645 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 02/NOV/2022, OF THE 228 DEVICES RELEASED TO FINISHED GOODS FOR LOT S10645, 216 HAVE BEEN DISTRIBUTED WITH 117 REPORTED AS IMPLANTED. BASED ON OUR INTERNAL INVESTIGATION WITH NO REMARKABLE FINDINGS, AND 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. AS REPORTED IN THE INITIAL: THIS LEGAL EVENT IS BEING REPORTED AS SERIOUS INJURY DUE TO THE REPORTED RECURRENCE WITH SURGICAL INTERVENTION. THE LOT ASSOCIATED WITH THIS EVENT IS S10645-118; HOWEVER, THE INTERNAL INVESTIGATION IS PENDING AND WILL BE REPORTED IN A FOLLOW UP REPORT ALONG WITH THE INVESTIGATION CONCLUSION.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A LEGAL EVENT THAT A 37 YEAR OLD MALE PATIENT HAD VENTRAL HERNIA REPAIR SURGERY ON (B)(6) 2010. DURING THE HERNIA REPAIR SURGERY, THE PATIENTS SURGEON, DR. (B)(6) AT (B)(6), IMPLANTED A STRATTICE MESH IN HIM. LOT NUMBER S10645-118, CATALOG 1016002. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2011, FOR A MESH REMOVAL OPERATION. ON OR ABOUT (B)(6) 2011, DR. (B)(6) IMPLANTED A SECOND STRATTICE FIRM MESH. LOT NUMBER S10980-092, CATALOG 1820002. THIS RECORD IS ASSOCIATED WITH LOT S10645-118 IMPLANTED ON (B)(6) 2010.

    Description of Event or Problem · 0

    THIS IS FOLLOW UP#1 TO REPORT THE RESULTS FROM THE INTERNAL INVESTIGATION AND THE CONCLUSION. THE AWARE DATE OF NOVEMBER 2, 2022 IS BASED ON WHEN THE BATCH RECORD REVIEW WAS COMPLETED. AS REPORTED IN THE INITIAL: IT WAS REPORTED THROUGH A LEGAL EVENT THAT A 37 YEAR OLD MALE PATIENT HAD VENTRAL HERNIA REPAIR SURGERY ON (B)(6) 2010. DURING THE HERNIA REPAIR SURGERY, THE PATIENTS SURGEON, DR. MATTHEW VASSY AT DEACONESS HEALTH SYSTEM, IMPLANTED A STRATTICE MESH IN HIM. LOT NUMBER S10645-118, CATALOG 1016002. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OCTOBER 7, 2011, FOR A MESH REMOVAL OPERATION. ON OR ABOUT (B)(6) 2011, DR. (B)(6) IMPLANTED A SECOND STRATTICE FIRM MESH. LOT NUMBER S10980-092, CATALOG 1820002. THIS RECORD IS ASSOCIATED WITH LOT S10645-118 IMPLANTED ON (B)(6) 2010. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638673 STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 16, FIRM MESH, SURGICAL FTM S10645

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male Required Intervention NO INFORMATION