BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE

    MDR report key: 2070899 · Received April 27, 2011

    Report

    Report Number
    2210968-2011-00515
    Event Type
    Injury
    Date Received
    April 27, 2011
    Report Date
    March 30, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    GAS
    PMA / PMN Number
    N17804
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 04/27/2011. (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A VALVE REPLACEMENT PROCEDURE ON (B)(6) 2010 AND SUTURE WAS USED. THE PATIENT EXPERIENCED A POST-OPERATIVE INFECTION OF THE VALVE AT THE SITE WHERE THE SUTURE ATTACHED TO THE VALVE. THE INFECTION REQUIRED A REPEAT SURGERY AND REPLACEMENT OF THE VALVE AND EXTENDED HOSPITAL STAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE SUTURE, NON-ABSORBABLE GAS ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R