BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 30, FIRM

    MDR report key: 14435248 · Received May 19, 2022

    Report

    Report Number
    1000306051-2022-00091
    Event Type
    Injury
    Date Received
    May 19, 2022
    Date of Event
    August 27, 2020
    Report Date
    August 24, 2023
    Product Code
    FTM
    UDI-DI
    00818410010393
    PMA / PMN Number
    K150712
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS LEGAL EVENT IS BEING REPORTED AS SERIOUS INJURY DUE TO THE REPORTED RECURRENCE WITH SURGICAL INTERVENTION. INTERNAL INVESTIGATION INTO STRATTICE LOT SP100606 INCLUDED A REVIEW OF THE REPORTED INFORMATION, REVIEW OF THE DEVICE HISTORY RECORDS, AND A REVIEW OF THE COMPLAINT HISTORY RECORDS WITH NO REMARKABLE FINDINGS, INCLUDING NO OTHER COMPLAINTS REPORTED AGAINST THE LOT AND NO DEVIATIONS OR NON-CONFORMANCES REVEALED DURING PROCESSING. THE LOT WAS ASEPTICALLY PROCESSED, TERMINALLY STERILIZED WITHIN THE PROCESS PARAMETERS, AND MET ALL QC RELEASE CRITERIA. TO DATE, OF THE (B)(4) DEVICES RELEASED TO FINISHED GOODS, (B)(4) HAVE BEEN DISTRIBUTED WITH (B)(4) DEVICES REPORTED AS IMPLANTED. 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 IS A FOLLOW UP #1 REPORT TO THE INTERNAL INVESTIGATION AND CONCLUSION. THIS LEGAL EVENT IS BEING REPORTED AS SERIOUS INJURY DUE TO THE REPORTED RECURRENCE WITH SURGICAL INTERVENTION. INTERNAL INVESTIGATION INTO STRATTICE LOT SP100605 INCLUDED A REVIEW OF THE REPORTED INFORMATION, REVIEW OF THE DEVICE HISTORY RECORDS, AND A REVIEW OF THE COMPLAINT HISTORY RECORDS WITH NO REMARKABLE FINDINGS, INCLUDING NO OTHER COMPLAINTS REPORTED AGAINST THE LOT AND NO DEVIATIONS OR NON-CONFORMANCES REVEALED WITH PRODUCT IMPACT. THE LOT WAS ASEPTICALLY PROCESSED, TERMINALLY STERILIZED WITHIN THE PROCESS PARAMETERS, AND MET ALL QC RELEASE CRITERIA. TO DATE, ALL 158 DEVICES RELEASED TO FINISHED GOODS HAVE BEEN DISTRIBUTED WITH 86 DEVICES REPORTED AS IMPLANTED. 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 (B)(6) MALE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2019. DURING THE PATIENT¿S SURGERY, THE SURGEON IMPLANTED HIM WITH STRATTICE LOT SP100606 (SKU 2030002). AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2020, AND WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA, ADHESIONS, CHRONIC SEROMA, AND SMALL BOWL LINING DETERIORATION DUE TO MESH. ON OR ABOUT (B)(6) 2020, THE PATIENT UNDERWENT LYSIS OF ADHESIONS AND HERNIA REPAIR. DURING THIS REVISION SURGERY, THE SURGEON NOTED INTRA-ABDOMINAL ADHESIONS INVOLVING THE SMALL BOWEL, OMENTUM, TRANSVEST COLON, ANTERIOR ABDOMINAL WALL, AND PREVIOUSLY PLACED MESH. THE SURGEON ALSO NOTED THAT THE GRAFT APPEARED FOLDED ON ITSELF AND BUNCHED UP ALONG THE FASCIAL DEFECT. MULTIPLE LOOPS OF SMALL BOWEL WERE NOTED TO BE DECENTLY ADHERENT MESH WITH SEROSAL EROSION AND A SEROMA ANTERIOR TO THE PREVIOUSLY PLACED MESH. IT SHOULD BE THE NOTED THE LOT NUMBER WAS PROVIDED WITHOUT THE SERIAL NUMBER AND THE ITEM NUMBER THAT CORRELATES IS 2030002P.

    Description of Event or Problem · 0

    THIS IS FOLLOW-UP #1 TO REPORT ADDITIONAL INFORMATION REPORTING THE LOT NUMBER ASSOCIATED WITH THIS COMPLAINT. LOT SP100605-026. AS REPORTED IN THE INITIAL: IT WAS REPORTED THROUGH A LEGAL EVENT THAT A 55-YEAR-OLD MALE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2019. DURING THE PATIENT¿S SURGERY, THE SURGEON IMPLANTED HIM WITH STRATTICE LOT SP100606 (SKU 2030002). AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2020, AND WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA, ADHESIONS, CHRONIC SEROMA, AND SMALL BOWL LINING DETERIORATION DUE TO MESH. ON OR ABOUT (B)(6), 2020, THE PATIENT UNDERWENT LYSIS OF ADHESIONS AND HERNIA REPAIR. DURING THIS REVISION SURGERY, THE SURGEON NOTED INTRA-ABDOMINAL ADHESIONS INVOLVING THE SMALL BOWEL, OMENTUM, TRANSVEST COLON, ANTERIOR ABDOMINAL WALL, AND PREVIOUSLY PLACED MESH. THE SURGEON ALSO NOTED THAT THE GRAFT APPEARED FOLDED ON ITSELF AND BUNCHED UP ALONG THE FASCIAL DEFECT. MULTIPLE LOOPS OF SMALL BOWEL WERE NOTED TO BE DECENTLY ADHERENT MESH WITH SEROSAL EROSION AND A SEROMA ANTERIOR TO THE PREVIOUSLY PLACED MESH. IT SHOULD BE THE NOTED THE LOT NUMBER WAS PROVIDED WITHOUT THE SERIAL NUMBER AND THE ITEM NUMBER THAT CORRELATES IS(B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1977032 STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 30, FIRM MESH, SURGICAL FTM SP100605 00818410010393

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention NO INFORMATION REPORTED| NO INFORMATION REPORTED