BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILK SUTURE

    MDR report key: 266951 · Received March 1, 2000

    Report

    Report Number
    1610287-2000-00003
    Event Type
    Injury
    Date Received
    March 1, 2000
    Report Date
    January 31, 2000
    Manufacturer
    ALCON PRECISION DEVICE MGG. FACILITY
    Product Code
    GAP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RPTR NOTED SEVERAL SURGEONS WERE HAVING PROBLEMS WITH THIS LOT OF SUTURES. ONE SURGEON HAD 2 PTS ON THE SAME DAY WITH FRAYED SUTURES. POST-OP FOLLOW-UP NOTED IRIS HERNIA(PROLAPSE). THIS PT HAD SECOND SURGICAL PROCEDURE AND SUTURES WERE REPLACED. CASES RESOLVED WITHOUT FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILK SUTURE SUTURE GAP ALCON PRECISION DEVICE MGG. FACILITY 8065703901 M316750

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention