BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYSORB 3/0 30 U/D V-20 115Q

    MDR report key: 2120469 · Received June 3, 2011

    Report

    Report Number
    1219930-2011-00403
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    April 28, 2011
    Report Date
    May 3, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GAM
    PMA / PMN Number
    K963253
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: BREAST REDUCTION. ACCORDING TO THE REPORTER: THE TIP OF THE NEEDLE BROKE OFF IN THE PATIENT. THE TIP WAS RETRIEVED. A NEW SUTURE WAS OPENED TO COMPLETE THE CASE. THE OPERATING ROOM TIME WAS DELAYED 30 MINUTES. TISSUE DAMAGE OCCURRED DUE TO ADDITIONAL DISSECTION. NO BLEEDING WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYSORB 3/0 30 U/D V-20 115Q ABSORBABLE SUTURE PRODUCT GAM UNITED STATES SURGICAL A1B0174G

    Patients

    Seq Age Sex Outcome Treatment
    1 Other