BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STRATTICE

    MDR report key: 14990207 · Received July 12, 2022

    Report

    Report Number
    1000306051-2022-00118
    Event Type
    Injury
    Date Received
    July 12, 2022
    Date of Event
    March 18, 2018
    Report Date
    July 12, 2022
    Product Code
    FTM
    PMA / PMN Number
    K070560
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS LEGAL EVENT IS BEING REPORTED AS SERIOUS INJURY DUE TO THE REPORTED INFECTION WITH SURGICAL INTERVENTION. THE LOT ASSOCIATED WITH THIS EVENT WAS NOT REPORTED AND REMAINS UNKNOWN; THEREFORE AN INTERNAL INVESTIGATION INTO THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. NO STRATTICE DEVICES WERE RETURNED FOR EVALUATION. BASED ON THE LIMITED INFORMATION, INCLUDING NO IDENTIFICATION OF THE LOT NUMBER, AND WITHOUT RELEVANT PATIENT FACTORS, A RELATIONSHIP BETWEEN THE EVENT AND THE STRATTICE 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 (B)(6) 2017 AND UNDERWENT AN INCISION AND DEBRIDEMENT FOR ABDOMINAL ABSCESS AND HAD A WOUND VAC PLACED. THIS RECORD IS ASSOCIATED WITH THE SECOND MESH IMPLANTED IN (B)(6) 2017, RECORD 2 OF 2, DATE OF OCCURRENCE (B)(6) 2018. SINCE THE INFORMATION PROVIDED DOES NOT INDICATE IF THE ADDITIONAL MESH THAT WAS PLACED IS STRATTICE, IT WILL BE ASSUMED TO BE STRATTICE, LOT UNKNOWN UNTIL FURTHER CLARIFICATION IS/IF RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652790 UNKNOWN STRATTICE MESH, SURGICAL FTM NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention NO INFORMATION