BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPOSIX L/P W/ ECHO

    MDR report key: 6982804 · Received October 27, 2017

    Report

    Report Number
    1213643-2017-00733
    Event Type
    Injury
    Date Received
    October 27, 2017
    Report Date
    October 27, 2017
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K122436
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS HAVE BEEN MADE TO CONTACT THE PATIENT TO REQUEST PRODUCT IDENTIFIERS AND ADDITIONAL INFORMATION. BASED ON THE INFORMATION PROVIDED AT THIS TIME, WE ARE UNABLE TO DETERMINE TO WHAT EXTENT, IF ANY THE BARD DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENTS AS ALLEGED. WITHOUT A LOT NUMBER A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE, SHOULD ADDITIONAL INFORMATION BE PROVIDED, A SUPPLEMENTAL MDR WILL SUBMITTED. THE INFORMATION PROVIDED BY BARD 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 BARD. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN (B)(6) 2014 THE PATIENT HAD A BARD COMPOSIX LP W/ ECHO PLACED. IT IS REPORTED THAT THE PATIENT HAS EXPERIENCED PAIN, A MOVING SENSATION, TENDERNESS OF THE SKIN AND BOWEL ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762356 COMPOSIX L/P W/ ECHO SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other