BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURE TRIMMER

    MDR report key: 1913248 · Received December 2, 2010

    Report

    Report Number
    2953144-2010-03070
    Event Type
    Injury
    Date Received
    December 2, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 8, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ESTIMATED DATE (REPORTED AS "RECENTLY OCCURRED").THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF AN UNSPECIFIED ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE SUTURE TRIMMER DID NOT CUT THE SUTURE AND A SCALPEL WAS USED TO CUT THE SUTURE. HEMOSTASIS WAS ACHIEVED WITH THE DEVICE. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUTURE TRIMMER SUTURE MEDIATED CLOSURE MGB AV-REDWOOD CITY

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention