BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYSORB UD 4/0 18 P-11

    MDR report key: 1861940 · Received October 5, 2010

    Report

    Report Number
    1219930-2010-00775
    Event Type
    Injury
    Date Received
    October 5, 2010
    Report Date
    September 9, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GAM
    PMA / PMN Number
    K963253
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE NEEDLE BROKE OFF FROM THE SUTURE THREAD WHILE THE SURGEON WAS TENDING TO AN ARTERIAL BLEED AND IT BECAME LOST IN THE WOUND. THE NEEDLE TIP WAS UNABLE TO BE LOCATED, AND THE NEEDLE WAS REMOVED BY THE PLASTICS TEAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYSORB UD 4/0 18 P-11 ABSORBABLE SUTURE PRODUCT GAM UNITED STATES SURGICAL A9E0807

    Patients

    Seq Age Sex Outcome Treatment
    1 Other