BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 1915051 · Received November 30, 2010

    Report

    Report Number
    1213643-2010-00507
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    December 26, 2006
    Report Date
    November 1, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFORMATION, INCLUDING MEDICAL RECORDS. THE PATIENT'S HUSBAND PROVIDED TWO LOT NUMBERS LISTED FOR 0010201, BUT STATED THAT ONLY ONE OF THE LOTS WAS IMPLANTED. THE PATIENT WAS IMPLANTED WITH EITHER 43HND420 OR 43COD242. A REVIEW OF THE MANUFACTURING RECORDS WAS CONDUCTED FOR BOTH LOTS AND ALL PAPERWORK APPEARED COMPLETE AND ACCURATE AND THERE WAS NO EVIDENCE OF A MANUFACTURING RELATED CAUSE FOR THE REPORTED EVENTS. CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. BASED ON THE INFORMATION AVAILABLE, NO CONCLUSION CAN BE DRAWN AT THIS TIME. THIS IS THE FIRST OF THE THREE MESH IMPLANTS/EXPLANTS IDENTIFIED IN THE EVENT DESCRIPTION. THE OTHER TWO ARE IDENTIFIED IN MEDWATCH 1213643-2010-00508 AND 12123643-2010-00509.

    Description of Event or Problem · 1

    ON (B)(6) 2006, PATIENT HAD INCISIONAL HERNIA REPAIR WITH MESH A TOTAL OF 3 DAVOL/BARD MESH IMPLANTS. ON (B)(6) 2006, PATIENT PRESENTED TO ER WITH PAIN. THE PATIENT WAS DIAGNOSED WITH AN INFECTION AND A POSSIBLE BOWEL PERFORATION. ON (B)(6) 2006, PATIENT UNDERWENT UNKNOWN OPERATIVE PROCEDURE AND REPORTS REMOVAL OF MESH DUE TO MESH INFECTION, BOWEL PUNCTURE AND SEVERE INFLAMMATION. THE PATIENT UNDERWENT ANTIBIOTIC AND TPN THERAPY VIA PICC LINE. ON (B)(6) 2010, PATIENT UNDERWENT ABDOMINAL RECONSTRUCTION WITH MESH (WITH ANOTHER MANUFACTURER'S MESH) TO REPAIR HERNIA RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43HND420

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention