BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    23GA POSTERIOR VITRECTOMY PACK W/I11

    MDR report key: 3243234 · Received July 19, 2013

    Report

    Report Number
    1920664-2013-00194
    Event Type
    Malfunction
    Date Received
    July 19, 2013
    Report Date
    June 20, 2013
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQC
    PMA / PMN Number
    K101325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. INFORMATION PROVIDED BY THE CUSTOMER INDICATES ADDITIONAL SIMILAR EVENTS MAY HAVE OCCURRED, HOWEVER, THEY WERE UNABLE TO PROVIDE SPECIFIC DETAILS REGARDING THE ACTUAL NUMBER OF PATIENTS AND DEVICES INVOLVED. NUMBER 2 OF 4.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6) STATED THAT THE TROCAR WAS BENT AND DID NOT ALLOW A CORRECT INSERTION OF THE CANNULA. THE SURGEON HAD TO APPLY PRESSURE TO INSERT THE TROCAR CAUSING BLEEDING IN THE SCLEROCORNEAL TISSUE. THERE WAS NO MEDICAL INTERVENTION NEEDED AND THE PATIENT DID NOT SUFFER ANY CONSEQUENCES OR FURTHER INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338239 23GA POSTERIOR VITRECTOMY PACK W/I11 HQC BAUSCH & LOMB U9062

    Patients

    Seq Age Sex Outcome Treatment
    1