BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 2870265 · Received December 12, 2012

    Report

    Report Number
    2210968-2012-08132
    Event Type
    Injury
    Date Received
    December 12, 2012
    Report Date
    November 20, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2012-05031. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN AUSTIN KALISH STYLE BUNIONECTOMY OF THE RIGHT FOOT, SINGLE SCREW FIAXATION, EXCISIN OF NEUROMA 2ND AND 3RD INTERSPACES OF THE RIGHT FOOT, AND REPAIR OF JOINT CAPSULE TEAR NUMBER 4 MTPJ OF THE RIGHT FOOT ON (B)(6) 2012 AND SUTURE WAS USED. ON (B)(6) 2012, THE PATIENT NOTICED WHITE BUMPS AND SCAR TISSUE. ALSO, THE WOUND APPEARED TO HAVE OPENED. THE SURGEON REMOVED THE KNOTS THAT WERE COMING THROUGH THE SKIN AND PRESCRIBED ANTIBIOTICS AND HYDROCODONE FOR THE PAIN. THE PATIENT IS EXPERIENCING CONSTANT PAIN AND PRESSURE.

    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 61 YR Required Intervention