BEUDAMED
    FDA Adverse Event Death Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 245015 · Received October 12, 1999

    Report

    Report Number
    2210968-1999-00470
    Event Type
    Death
    Date Received
    October 12, 1999
    Date of Event
    September 1, 1994
    Report Date
    September 21, 1999
    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

    RECEIVED COMPLAINT THAT ALLEGES THE PT UNDERWENT ORTHOPEDIC SURGERY USING THE SUTURE AND SUBSEQUENTLY DEVELOPED AN INFECTION. PT EXPIRED AS A RESULT OF INFECTION. NO FURTHER INFO IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death