BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 384380 · Received March 26, 2002

    Report

    Report Number
    2210968-2002-00213
    Event Type
    Injury
    Date Received
    March 26, 2002
    Date of Event
    February 12, 2002
    Report Date
    February 13, 2002
    Manufacturer
    ETHICON, INC. SAN ANGELO
    Product Code
    GAM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A ROTATOR CUFF, BANKHART PROCEDURE THE PATIENT DEVELOPED A POST OPERATIVE WOUND INFECTION.

    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 QH7944

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR