BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 16 X 20, FIRM

    MDR report key: 16860675 · Received May 3, 2023

    Report

    Report Number
    1000306051-2023-00094
    Event Type
    Injury
    Date Received
    May 3, 2023
    Date of Event
    October 24, 2014
    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

    THIS LEGAL EVENT IS BEING REPORTED AS SERIOUS INJURY DUE TO THE REPORTED RECURRENCE WITH SURGICAL INTERVENTION. 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 S11242 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 03 MAY 2023, ALL OF THE 219 DEVICES RELEASED TO FINISHED GOODS FOR LOT S11242 HAVE BEEN DISTRIBUTED WITH 97 REPORTED AS IMPLANTED. LOT S11242 WAS PROCESSED ASEPTICALLY, TERMINALLY STERILIZED AND MET ALL QC RELEASE CRITERIA. AS REPORTED IN THE INITIAL: THIS LEGAL EVENT IS BEING REPORTED AS SERIOUS INJURY DUE TO THE REPORTED RECURRENCE WITH SURGICAL INTERVENTION. 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 PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT JULY 3, 2013. DURING HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH, LOT NUMBER S11242-128. THE RECORDS INDICATE THE DEVICE WAS A STRATTICE MESH. AFTER SURGERY, PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT OCTOBER 24, 2014, FOR A REMOVAL AND REVISION SURGERY AND ADDITIONAL STRATTICE MESH WAS IMPLANTED (LOT# SP100082; REF # 2020002).

    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 IS BASED ON WHEN THE BATCH RECORD REVIEW WAS COMPLETED. AS REPORTED IN THE INITIAL: IT WAS REPORTED THROUGH A LEGAL EVENT THAT A PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2013. DURING HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH, LOT NUMBER S11242-128. THE RECORDS INDICATE THE DEVICE WAS A STRATTICE MESH. AFTER SURGERY, PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2014, FOR A REMOVAL AND REVISION SURGERY AND ADDITIONAL STRATTICE MESH WAS IMPLANTED (LOT# SP100082; REF # 2020002).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860016 STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 16 X 20, FIRM MESH, SURGICAL FTM LIFECELL S11242

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Unknown Required Intervention NO INFORMATION REPORTED