BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STRATTICE

    MDR report key: 16125981 · Received January 9, 2023

    Report

    Report Number
    1000306051-2022-00229
    Event Type
    Injury
    Date Received
    January 9, 2023
    Date of Event
    January 30, 2015
    Report Date
    January 9, 2023
    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 RECURRENCE 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 71 YEAR OLD MALE PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2013. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH. THE RECORDS INDICATE THIS IS A LIFECELL ¿ STRATTICE MESH (LOT # SP1000005-149 REF # 1010002). AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2015, FOR A REVISION SURGERY AND ADDITIONAL STRATTICE MESH WAS IMPLANTED. THE RECORDS INDICATE THIS IS A LIFECELL ¿ STRATTICE MESH (LOT # SP100157 REF #1016002). ON (B)(6) 2016, THE PATIENT UNDERWENT AN INCISIONAL VENTRAL HERNIA REPAIR WITH STRATTICE. THE RECORDS INDICATE THAT TWO STRATTICE WERE IMPLANTED (CAT # 0808002 LOT # SP100300- 213; LOT # SP100176-204). IT WAS REPORTED THE PATIENT UNDERWENT MULTIPLE SUBSEQUENT RECURRENT VENTRAL AND INCISIONAL HERNIA REPAIR SURGERIES. NO OTHER INFORMATION WAS PROVIDED. THIS RECORD IS ASSOCIATED WITH DEVICE LOT # SP1000005-149 REF # 1010002, IMPLANTED (B)(6) 2013. ALTHOUGH A LOT NUMBER WAS REPORTED, SP1000005-149 IS NOT A VALID LOT NUMBER AND THEREFORE DEFAULTED TO UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1564038 UNKNOWN STRATTICE MESH, SURGICAL FTM NI

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention NO INFORMATION REPORTED