BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 16, FIRM

    MDR report key: 14989110 · Received July 12, 2022

    Report

    Report Number
    1000306051-2022-00115
    Event Type
    Injury
    Date Received
    July 12, 2022
    Date of Event
    May 19, 2021
    Report Date
    October 25, 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

    INTERNAL INVESTIGATION INTO STRATTICE LOT S11041 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 6/30/2022, OF THE (B)(4) DEVICES RELEASED TO FINISHED GOODS FOR LOT S11041, (B)(4) HAVE BEEN DISTRIBUTED WITH (B)(4) 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. DUE TO THE LEGAL PROCESS, IF ADDITIONAL INFORMATION IS MADE AVAILABLE DURING LEGAL PROCEEDINGS, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE INDIVIDUAL PIECE THAT WAS IMPLANTED FROM LOT S11041 WAS IDENTIFIED AS PIECE (B)(4). THE INVESTIGATION CONCLUSION THAT WAS REPORTED IN THE INITIAL MEDWATCH THAT IS ASSOCIATED WITH LOT S11041 REMAINS THE SAME. THE INVESTIGATION WAS PERFORMED ON THE ENTIRE LOT SO THE PIECE NUMBER WAS INCLUDED WITHIN THE INVESTIGATION. THE RELATIONSHIP TO THE STRATTICE REMAINS UNDETERMINED. AS REPORTED IN THE INITIAL: INTERNAL INVESTIGATION INTO STRATTICE LOT S11041 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 06/30/2022, OF THE (B)(4) DEVICES RELEASED TO FINISHED GOODS FOR LOT S11041, (B)(4) HAVE BEEN DISTRIBUTED WITH (B)(4) 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A LEGAL EVENT THAT A 54 YEAR OLD FEMALE HAD PRIMARY VENTRAL HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2012. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH IN HER, LOT NUMBER 811041, REFERENCE NUMBER FOR THAT MESH IS 1016002. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2021 AND UNDERWENT A REVISION AND REMOVAL SURGERY OF THE STRATTICE MESH. SHE UNDERWENT A SUBSEQUENT REVISION SURGERY IN (B)(6) 2021. BASED ON THE CATALOG NUMBER AND LIFECELL'S LOT NUMBER FORMAT, THE '8' IS CONSIDERED A TYPO AND THE VALID LOT NUMBER ASSOCIATED WITH THIS EVENT IS S11041.

    Description of Event or Problem · 0

    THIS IS FOLLOW UP#1 TO REPORT ON 17/OCT/2022, PMQA RECEIVED NOTIFICATION FROM LEGAL THAT THE LOT ASSOCIATED WITH THIS EVENT WAS FOUND THROUGH DISCOVERY AND IS S11041-116. NO OTHER INFORMATION WAS REPORTED THE LOT NUMBER WAS ALREADY PROVIDED IN THE ORIGINAL SUMMONS, HOWEVER THE NEW INFORMATION FOUND THROUGH DISCOVERY REPORTED THE INDIVIDUAL SUBLOT OF (B)(4). THE INVESTIGATION WAS ALREADY PREFORMED ON S11041 WHICH INCLUDED PIECE (B)(4). THE RECORD BEEN UPDATED TO INDICATE THE FULL LOT OF S11041-116. AS REPORTED IN THE INITIAL: IT WAS REPORTED THROUGH A LEGAL EVENT THAT A 54 YEAR OLD FEMALE HAD PRIMARY VENTRAL HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2012. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH IN HER, LOT NUMBER 811041, REFERENCE NUMBER FOR THAT MESH IS 1016002. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT MAY 19, 2021 AND UNDERWENT A REVISION AND REMOVAL SURGERY OF THE STRATTICE MESH. SHE UNDERWENT A SUBSEQUENT REVISION SURGERY IN NOVEMBER 2021. BASED ON THE CATALOG NUMBER AND LIFECELL'S LOT NUMBER FORMAT, THE '8' IS CONSIDERED A TYPO AND THE VALID LOT NUMBER ASSOCIATED WITH THIS EVENT IS S11041.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652733 STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 16, FIRM MESH, SURGICAL FTM S11041

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention