BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOWMAN LACRINAL PROBES, SIZES 0000 & 000

    MDR report key: 11882722 · Received May 26, 2021

    Report

    Report Number
    2523190-2021-00101
    Event Type
    Injury
    Date Received
    May 26, 2021
    Date of Event
    April 27, 2021
    Report Date
    June 23, 2021
    Product Code
    HNL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED VIA MEDWATCH #MW5101071 INDICATES THAT THE TIP OF THE LACRINAL PROBE BROKE OFF IN THE PATIENT DURING USE LEAVING A SMALL LINEAR MENTAL FRAGMENT THAT HAD TO BE REMOVED IN A SECOND SURGERY. THIS WAS DISCOVERED BY AN X-RAY SCAN. ALL THE BROKEN PARTS WERE RECOVERED. THE BOWMAN LACRINAL PROBE (360271) WAS NOT RETURNED FOR EVALUATION; HOWEVER AN IMAGE WAS PROVIDED FOR EVALUATION: THE REPORTED COMPLAINT IS CONFIRMED. PER THE PROVIDED IMAGE, THE 360271 PROBE HAD ITS END BROKEN OFF DUE TO ROUGH HANDLING OR ENVIRONMENTAL DAMAGE. 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.

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A FACILITY REPORTED THAT THE BOWMAN LACRINAL PROBE (360271) BROKE OFF IN A PATIENT DURING AN UNSPECIFIED PROCEDURE. THERE WAS NO PATIENT INJURY AND DELAY IN SURGERY IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787608 BOWMAN LACRINAL PROBES, SIZES 0000 & 000 N/A HNL AZ1905

    Patients

    Seq Age Sex Outcome Treatment
    1