BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 316920 · Received February 22, 2001

    Report

    Report Number
    2210968-2001-00049
    Event Type
    Injury
    Date Received
    February 22, 2001
    Date of Event
    December 16, 1995
    Report Date
    January 23, 2001
    Manufacturer
    ETHICON, INC. SAN ANGELO
    Product Code
    GAM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ATTORNEY THAT THE PLAINTIFF UNDERWENT A THREE VESSEL AORTOCORONARY BYPASS SURGERY ABOUT 11/1995 WHERE ETHICON SUTURES WERE USED. THE ATTORNEY ALLEGES THAT THE PLAINTIFF UNDERWENT A SECOND PROCEDURE ON THE EVENT DATE FOR THE DEBRIDEMENT OF A STERNAL WOUND WITH A PARTIAL OSTECTOMY AND REMOVAL OF TWO WIRES. REPORTEDLY, A THIRD PROCEDURE FOR THE DEBRIDEMENT OF THE STERNAL WOUND AND PECTORALIS FLAP WAS PERFORMED IN 11/1996.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6947 COATED VICRYL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. SAN ANGELO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention