BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGNIFYING LPE 3.0X BLK R 13IN TO 16IN WRKG DIST

    MDR report key: 15734535 · Received November 4, 2022

    Report

    Report Number
    3014334038-2022-00243
    Event Type
    Injury
    Date Received
    November 4, 2022
    Date of Event
    October 10, 2022
    Report Date
    December 22, 2022
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    HJH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE MAGNIFYING LOUPE (1-5016) WAS RETURNED FOR EVALUATION: THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES RELATED TO THE REPORTED ISSUE WERE IDENTIFIED. FAILURE ANALYSIS - THE RETURNED MAGNIFYING LOUPE WAS RECEIVED IN USED CONDITION WITH NO VISIBLE DEFECT. VISUAL/FUNCTIONAL EVALUATION NOTED THAT THE UNIT MET SPECIFICATIONS AND WAS ABLE TO MAGNIFY WITHOUT ISSUE. THE ISSUE OF CAUSING DIZZINESS COULD NOT BE DUPLICATED. ROOT CAUSE - THE MAGNIFYING LOUPE MET SPECIFICATIONS AND FUNCTIONED AS INTENDED. THE ISSUE OF CAUSING DIZZINESS. MAY BE THE RESULT OF USER PREFERENCE. THE PRODUCT USES MAGNIFYING LENSES THAT MAY SHOW OBJECTS OUT OF FOCUS WHEN VIEWED AT ODD ANGLES. PER THE INSTRUCTIONS FOR USE (IFU), THE LOUPE BARRELS SHOULD BE AGAINST OR CLOSE TO THE EYE SHIELD WITH THE LOUPES BETWEEN A 45° AND 60° ANGLE. NO MANUFACTURING, WORKMANSHIP OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED. NO FURTHER INVESTIGATION REQUIRED BASED ON THE ACCEPTABILITY OF RISK AND NO ADVERSE TRENDS IDENTIFIED. THIS WILL BE MONITORED AND TRENDED GOING FORWARD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE USER EXPERIENCED DIZZINESS WHEN THEY USED THE MAGNIFYING LPE 3.0X BLK R 13IN TO 16IN WORKING DISTANCE (1-5016). USER HEALTH OUTCOME IS UNKNOWN AT THIS TIME; HOWEVER, NO DEATH OR SURGICAL DELAY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2252040 MAGNIFYING LPE 3.0X BLK R 13IN TO 16IN WRKG DIST M5 - GENERAL SURGERY HJH INTEGRA LIFESCIENCES MANSFIELD 1-5016 4268549

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown