BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 273540 · Received April 14, 2000

    Report

    Report Number
    2210968-2000-00077
    Event Type
    Injury
    Date Received
    April 14, 2000
    Date of Event
    November 30, 1994
    Report Date
    March 17, 2000
    Manufacturer
    ETHICON, INC. SAN ANGELO
    Product Code
    GAM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ATTORNEY THAT THE PLAINTIFF UNDERWENT SURGERY TO REMOVE A CALCANEAL BONE SPUR FROM THE RIGHT ACHILLES' TENDON IN 1994 AND THE VICRYL SUTURES WERE USED. ON 10/25/1994, THE PHYSICIAN PRESCRIBED KEFLEX FOR A POSSIBLE SOFT TISSUE INFECTION. ON 11/30/1994, THE PHYSICIAN FOUND THAT NECROTIC MATERIAL AND ABSCESSES IN THE SURGICAL WOUND SITE. THE WOUND WAS CULTURED AND WAS FOUND POSITIVE FOR STAPHYLOCOCCUS. PT WAS ADMITTED IN THE HOSPITAL ON 12/05/1994 AND UNDERWENT SURGERY TO INCISE, DEBRIDE, DRAIN AND CLOSE THE ACHILLES' TENDON WOUND SITE, AND IV ANTIBIOTICS WAS PRESCRIBED. CULTURED POSITIVE FOR STAPHYLOCOCCUS AUREUS WAS PRESCRIBED. CULTURED POSITIVE FOR STAPHYLOCOCCUS AUREUS AND NOT AUREUS. THE WOUND WAS DEBRIDED ON 12/08/1994. ON 12/10/1994 THE PLAINTIFF WAS DISCHARGED FROM THE HOSPITAL, KEFLEX FOLLOWED BY VANCOMYACIN WERE PRESCRIBED. PT WAS RE-ADMITTED IN THE HOSPITAL AND ON 01/09/1995 PT UNDERWENT ANOTHER IRRIGATION AND DEBRIDEMENT OF THE WOUND SITE. CULTURED POSITIVE FOR STAPH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention