BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOWMAN LACRIMAL PROBES, SIZES 1 & 2

    MDR report key: 3165149 · Received June 10, 2013

    Report

    Report Number
    2523190-2013-00028
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    April 26, 2013
    Report Date
    June 10, 2013
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    HNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    PER CUSTOMER MEDWATCH (B)(4) RECEIVED: LACRIMAL SUCTION PROBE NUMBER PLATE BROKE OFF IN SCRUBS HAND. UNK IF ANY INJURY, NOT INDICATED ON FORM. ADD'L INFO RECEIVED (5/22/2013) FROM CUSTOMER STATING THE PROCEDURE WAS REMOVAL OF A FOREIGN BODY-RIGHT FOOT. DEVICE WAS USED FOR GENTLE PROBING. NO HARM TO PT, EVENT OCCURRED IN THE SCRUB TECHNICIANS HAND. NO HARM TO SCRUB TECH. DEVICE WILL NOT BE RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261569 BOWMAN LACRIMAL PROBES, SIZES 1 & 2 NA HNL INTEGRA YORK, PA INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1