BEUDAMED
    FDA Adverse Event Death Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 288936 · Received August 9, 2000

    Report

    Report Number
    2210968-2000-00299
    Event Type
    Death
    Date Received
    August 9, 2000
    Date of Event
    May 27, 1999
    Report Date
    July 12, 2000
    Manufacturer
    ETHICON, INC. SAN ANGELO
    Product Code
    GAM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON OR ABOUT 10/03/1995 AND 11/13/1995 THE PT UNDERWENT SURGERIES IN WHICH VICRYL SUTURES WERE USED. IT WAS ALSO STATED THAT THE PT MAY HAVE BEEN EXPOSED TO VICRYL SUTURES IN THE COURSE OF SURGERIES PERFORMED ON DIFFERENT OR ADD'L OCCASIONS. AS PER THE ATTORNEY, THE EXPOSURE TO THE VICRYL SUTURES CAUSED THE PT TO DEVELOP AN INFECTION, BACTEREMIA, DISCITIS, ENDOCARDITIS AND ULTIMATELY DEATH ON 05/27/1999.

    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 78 YR Death