BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGNIFYING LPE 2.5X RED L 14IN TO 17IN WRKG DIST

    MDR report key: 9126966 · Received September 26, 2019

    Report

    Report Number
    2523190-2019-00116
    Event Type
    Malfunction
    Date Received
    September 26, 2019
    Date of Event
    September 16, 2019
    Report Date
    September 16, 2019
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    HJH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UDI INFORMATION: (B)(4). THE RETURNED GLASSES WERE RETURNED SHOWING WEAR AND ONE OF THE ARMS WAS BROKEN OFF. THE LOUPES WERE INTACT. THE COMPLAINT REPORT HAS BEEN CONFIRMED; DAMAGED WORN. THE ROOT CAUSE HAS NOT BEEN IDENTIFIED AS A WORKMANSHIP OR MATERIAL DEFICIENCY.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT ON (B)(6) 2019, THE 1-5002 MAGNIFYING LPE 2.5X RED L 14IN TO 17IN WRKG DIST WAS BROKEN. THERE WAS NO PATIENT CONTACT, INJURY OR SURGICAL DELAY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915703 MAGNIFYING LPE 2.5X RED L 14IN TO 17IN WRKG DIST M5 - GENERAL SURGERY HJH INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1