BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 40, FIRM

    MDR report key: 14989995 · Received July 12, 2022

    Report

    Report Number
    1000306051-2022-00117
    Event Type
    Injury
    Date Received
    July 12, 2022
    Date of Event
    August 16, 2017
    Report Date
    July 12, 2022
    Product Code
    FTM
    UDI-DI
    00818410010409
    PMA / PMN Number
    K070560
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL INVESTIGATION INTO STRATTICE LOT SP100235 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 184 DEVICES RELEASED TO FINISHED GOODS FOR LOT SP100235, 175 HAVE BEEN DISTRIBUTED WITH 126 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. 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 68 YEAR OLD PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2015. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH; MODEL/CATALOG NUMBER IS 2040002 AND THE LOT NUMBER IS SP100235-204. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2017 AND WAS DIAGNOSED WITH A RECURRENT INCISIONAL HERNIA AND UNDERWENT A REPAIR OF AN ABDOMINAL WALL HERNIA AND LYSIS OF ADHESIONS. THE BIOLOGIC MESH WAS NOTED TO HAVE DEGRADED AND REABSORBED, AND THERE WERE MULTIPLE LOOPS OF BOWEL WITHIN THE RECURRENT HERNIA. THE HERNIA WAS REPAIRED WITH THE PLACEMENT OF ADDITIONAL MESH. ON OR ABOUT (B)(6) 2018, THE PRESENTED WITH PAIN, SWELLING, AND DRAINAGE AT THE SITE OF THE VENTRAL HERNIA REPAIR FROM AUGUST 2017 AND UNDERWENT AN INCISION AND DEBRIDEMENT FOR ABDOMINAL ABSCESS AND HAD A WOUND VAC PLACED. THIS RECORD IS ASSOCIATED WITH SP100235-204, RECORD 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772509 STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 40, FIRM MESH, SURGICAL FTM SP100235 00818410010409

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Unknown Required Intervention NO INFORMATION