BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIPRO 5/0 36 BLUE CV-11 D/A

    MDR report key: 1900231 · Received November 10, 2010

    Report

    Report Number
    2647580-2010-00889
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    September 30, 2010
    Report Date
    October 12, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GAW
    PMA / PMN Number
    K010909
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: EYE SURGERY. ACCORDING TO THE REPORTER: SUTURE BREAKS AT DAY 9-10 POST OPERATIVELY. PT ALLEGEDLY REQUIRING RE-OPERATION ON THE RIGHT EYE. PT OUTCOME: TEMPORARY LOSS IN FUNCTIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGIPRO 5/0 36 BLUE CV-11 D/A NON-ABSORBABLE SUTURE PRODUCT GAW USSC PUERTO RICO TOA0405MV

    Patients

    Seq Age Sex Outcome Treatment
    1 Other