BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERPULSE HANDPIECE WITH FAN SPRAY TIP

    MDR report key: 2942049 · Received December 27, 2012

    Report

    Report Number
    2648666-2012-00391
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    November 29, 2012
    Report Date
    November 29, 2012
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    FQH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE FILED WHEN THE QUALITY INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE LEAKED A DISCOLORED WATERY SUBSTANCE DURING PREPARATION FOR USE. 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
    1 INTERPULSE HANDPIECE WITH FAN SPRAY TIP FQH STRYKER INSTRUMENTS PUERTO RICO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK