BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 2133703 · Received June 9, 2011

    Report

    Report Number
    1213643-2011-00272
    Event Type
    Injury
    Date Received
    June 9, 2011
    Report Date
    May 18, 2011
    Manufacturer
    DAVOL INC.
    Product Code
    FTL
    PMA / PMN Number
    K922916
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFORMATION AND TO REQUEST RETURN OF THE DEVICE FOR EVALUATION. THIS MDR INCLUDES ALL PATIENT, EVENT AND DEVICE INFORMATION DAVOL HAS RECEIVED TO DATE. CURRENTLY, IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. NO MEDICAL RECORDS HAVE BEEN PROVIDED, NO SPECIFIC DEVICE FAILURE HAS BEEN ALLEGED AND NO PRODUCT HAS BEEN RETURNED FOR EVALUATION. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    BASED ON ATTORNEY'S REPORT: NI/NI/NI - PATIENT UNDERWENT REPAIR OF A LEFT INGUINAL HERNIA WITH A PERFIX PLUG. ATTORNEY REPORTS THAT PATIENT HAS EXPERIENCED SIGNIFICANT PHYSICAL PAIN AND SUFFERING, PERMANENT INJURY AND PERMANENT AND SUBSTANTIAL DEFORMITY, AND HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFIX PLUG FTL DAVOL INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention| S