BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD SOFT MESH

    MDR report key: 15977584 · Received December 14, 2022

    Report

    Report Number
    1213643-2022-00793
    Event Type
    Injury
    Date Received
    December 14, 2022
    Date of Event
    November 5, 2022
    Report Date
    November 29, 2022
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    FTL
    UDI-DI
    00801741030918
    PMA / PMN Number
    K052155
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION AVAILABLE, NO CONCLUSIONS CAN BE MADE. INFORMATION IS LIMITED. REVIEW OF MANUFACTURING RECORDS CONFIRMS PRODUCT WAS MANUFACTURED TO SPECIFICATION. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FOR THIS MANUFACTURING LOT OF 210 UNITS RELEASED FOR DISTRIBUTION IN JULY 2021. THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. NOT RETURNED - REMAINS IMPLANTED.

    Description of Event or Problem · 0

    AS PER NMPA (CHINA FDA): AS REPORTED, THE PATIENT UNDERWENT AN INDIRECT HERNIA REPAIR PROCEDURE ON (B)(6) 2022 USING PRE-CUT BARD SOFT MESH. AS REPORTED FOLLOWING IMPLANT THE PATIENT HAD POST OPERATIVE WOUND REDNESS, ITCHING & SWELLING. AS REPORTED THE PATIENT WAS SUCCESSFULLY TREATED WITH ANTI-ALLERGY DEXAMETHASONE INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446650 BARD SOFT MESH SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA HUFT0618 00801741030918

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention