BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 277448 · Received May 5, 2000

    Report

    Report Number
    2210968-2000-00106
    Event Type
    Injury
    Date Received
    May 5, 2000
    Date of Event
    January 1, 1994
    Report Date
    April 7, 2000
    Manufacturer
    ETHICON, INC., SAN ANGELO
    Product Code
    GAM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ATTORNEY THAT THE PLAINTIFF UNDERWENT A TRANSVERSE RECTUS ABDOMINIS MUSCLE (TRAM) FLAP FOR RIGHT BREAST RECONSTRUCTION ON AUGUST 16, 1994. VICRYL SUTURES WERE USED DURING THE PROCEDURE. PT RECEIVED PROPLYACTIC ANTIBIOTICS PRE-OPERATIVELY. PT DEVELOPED AN INFECTION, SEPARATION OF PT'S ABDOMINAL WOUND, CELLULITUS, NERCROSIS AND DELAYED HEALING FOR OVER A YEAR BEFORE ABDOMINAL WOUND CONTRACTED DOWN. PT'S BREAST SCAR HEALING WAS ALSO PROLONGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention