BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGILAV PLUS HANDPIECE SET WITH SHOWERHEAD TIP, SOFT CONE SPLASH SHIELD & 10 F

    MDR report key: 3110585 · Received May 14, 2013

    Report

    Report Number
    0001811755-2013-01107
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 2013
    Manufacturer
    STRYKER INSTRUMENTS-PUERTO RICO
    Product Code
    FQH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): DISCARDED BY USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO SURGILAV PLUS HANDPIECE SETS WITH SHOWERHEAD TIPS, SOFT CONE SPLASH SHIELD & 10 F WERE DISCOVERED TO HAVE TEARS IN THE STERILE PACKAGING UPON RECEIPT AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, AND THERE WERE NO USER INJURIES OR ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213122 SURGILAV PLUS HANDPIECE SET WITH SHOWERHEAD TIP, SOFT CONE SPLASH SHIELD & 10 F LAVAGE, JET FQH STRYKER INSTRUMENTS-PUERTO RICO 1173012

    Patients

    Seq Age Sex Outcome Treatment
    1