BEUDAMED
    FDA Adverse Event Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 2141573 · Received June 17, 2011

    Report

    Report Number
    2210968-2011-00795
    Date Received
    June 17, 2011
    Report Date
    May 17, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    NI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A LINK TO AN INTERNET SUTURE SITE THAT A PT UNDERWENT AN ACL RECONSTRUCTION PROCEDURE FOR A TORN KNEE LIGAMENT IN 2005 AND SUTURE WAS USED. ONE WEEK LATER, THE PT DEVELOPED A FEVER AND HAD EXTREME PAIN IN THE KNEE. THE PT WAS DIAGNOSED WITH INFECTION OF THE KNEE. THE EMERGENCY DOCTOR DRAINED THE KNEE AND THE PT UNDERWENT SURGERY THE NEXT DAY TO CLEAR THE INFECTION. THE PT REMAINED IN THE HOSPITAL FOUR DAYS FOR ANTIBIOTICS VIA PIC LINE AND WAS GIVEN MORE ANTIBIOTICS TO TAKE AT HOME. DURING POST-OPERATIVE VISITS TO THE ORTHOPEDIC DOCTOR, THE PT COMPLAINED THAT PUS WAS COMING OUT OF THE INCISION WITH PAIN AND SUTURE SPITTING AND GRANULOMA FORMATION. THE SURGEON REMOVED A FEW SUTURES. THE PT WAS DIAGNOSED WAS (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention