BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLSORB 2/0 30 VIOT V-30 225R

    MDR report key: 1832022 · Received September 8, 2010

    Report

    Report Number
    1219930-2010-00696
    Event Type
    Injury
    Date Received
    September 8, 2010
    Date of Event
    June 23, 2010
    Report Date
    August 13, 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: ONE NEEDLE BROKE OFF AT THE TIP, AFTER ONE USE. THE SECOND NEEDLE BENT AT THE TIP AFTER ONE USE. THERE WAS NO VISIBLE INJURY TO THE PT. A SEARCH FOR THE NEEDLE BY THE OPERATING ROOM STAFF PROVED UNSUCCESSFUL. PT WAS INFORMED. SUTURES HAVE BEEN SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLSORB 2/0 30 VIOT V-30 225R ABSORBABLE SUTURE PRODUCT GAM UNITED STATES SURGICAL AOC1212

    Patients

    Seq Age Sex Outcome Treatment
    1 Other