BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG LIGHT

    MDR report key: 15880601 · Received November 29, 2022

    Report

    Report Number
    1213643-2022-00761
    Event Type
    Injury
    Date Received
    November 29, 2022
    Date of Event
    October 19, 2022
    Report Date
    November 14, 2022
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    FTL
    UDI-DI
    00801741031014
    PMA / PMN Number
    K092032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED, POST-IMPLANT OF THE PERFIX LIGHT PLUG THE PATIENT EXPERIENCED AN ALLERGIC REACTION (SKIN FLUSHING). LIMITED INFORMATION IS PROVIDED. BASED ON THE INFORMATION AVAILABLE, NO CONCLUSIONS CAN BE MADE. REVIEW OF MANUFACTURING RECORDS CONFIRMS PRODUCT WAS MANUFACTURED TO SPECIFICATION. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FOR THIS MANUFACTURING LOT OF (B)(4) UNITS RELEASED FOR DISTRIBUTION IN NOVEMBER,2020. 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.

    Description of Event or Problem · 0

    AS PER NMPA (CHINA FDA): AS REPORTED, THE PATIENT UNDERWENT RIGHT INDIRECT HERNIA HIGH LIGATION AND TENSION-FREE HERNIA REPAIR ON (B)(6) 2022 WITH THE IMPLANT OF BARD/DAVOL PERFIX PLUG LIGHT. LOCAL SKIN FLUSHING OCCURRED ON (B)(6) 2022, THE FOURTH DAY AFTER THE OPERATION, WHICH GRADUALLY SUBSIDED THROUGH DISINFECTION, AND NO OBVIOUS ABNORMALITY WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1959522 PERFIX PLUG LIGHT SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA HUEW1140 00801741031014

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention