BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 1944473 · Received December 28, 2010

    Report

    Report Number
    1213643-2010-00575
    Event Type
    Injury
    Date Received
    December 28, 2010
    Report Date
    December 6, 2010
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED AND NO PRODUCT IDENTIFIERS WERE PROVIDED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INITIAL RPTR WAS CONTACTED AND HAS REFUSED TO PROVIDE FURTHER INFO AND HAS REQUESTED THAT HE NOT BE CONTACTED FURTHER. THEREFORE, NO F/U CAN BE MADE. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR CURRENT KNOWLEDGE.

    Description of Event or Problem · 1

    ON (B)(6) 2010: THE PT SUBMITTED AN EMAIL TO INDICATING THAT HE HAD INGUINAL HERNIA TEN YRS PRIOR, AND STATES, "I HAD IT FIXED WITH YOUR PATCH." "I WAS DIAGNOSED WITH THE HERNIA AFTER SEVERE PAIN." THE PRODUCT APPEARS TO REMAIN IMPLANTED AT THIS TIME. THE PT ALLEGES A FAILED PATCH, HERNIA RECURRENCE, PAIN AND SUFFERING. THIS FILE IS ASSIGNED AS AN UNK COMPOSIX KUGEL MESH AS THE PT ALSO REFERENCES "A CLASS ACTION LAWSUIT" IN HIS EMAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other