BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 316587 · Received February 21, 2001

    Report

    Report Number
    2210968-2001-00047
    Event Type
    Injury
    Date Received
    February 21, 2001
    Date of Event
    December 1, 2000
    Report Date
    January 26, 2001
    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
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 16 DAYS AFTER A KPE WITH INTRAOCULAR LENS AND TRABECULECTOMY, THE PT HAD TO COME BACK FOR A WOUND REVISION DUE TO THE SUTURES DISSOLVING. THE PHYSICIAN FELT THAT THE SUTURES WERE DISSOLVING TO QUICKLY. AFTER WOUND REVISION NO FURTHER SURGICAL INTERVENTION WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6850 COATED VICRYL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. SAN ANGELO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR