BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURITAN TIPPED APPLICATOR

    MDR report key: 1638924 · Received March 19, 2010

    Report

    Report Number
    1216735-2010-00001
    Event Type
    Malfunction
    Date Received
    March 19, 2010
    Date of Event
    February 15, 2010
    Report Date
    March 12, 2010
    Manufacturer
    PURITAN MEDICAL PRODUCTS COMPANY LLC
    Product Code
    KXF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH RECORDS FOR LOT AND RETENTION SAMPLES EXAMINED. NO ANOMALIES WERE NOTED. MICROSCOPIC AND PHOTOGRAPHIC EVAL OF THE RETURNED DEVICE INDICATED MANIPULATION OF THE SHAFT. THE MANIPULATION CONTRIBUTED TO THE REPORTED EVENT. THIS CLAIM IS RECORDED AND THE APPROPRIATE INDIVIDUALS ARE NOTIFIED. THIS IS THE FIRST SUCH REPORT FROM APPROX 20 MILLION APPLICATORS DISTRIBUTED OVER 1.75 YEARS.

    Description of Event or Problem · 1

    TIP OF SWAB BROKE OFF IN PT'S NOSE; TIP REMOVED BY ENT DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PURITAN TIPPED APPLICATOR ABSORBENT TIPPED APPLICATOR KXF PURITAN MEDICAL PRODUCTS COMPANY LLC 25-1406 1 PFB 91/11 2350

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention