BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAIL NIPPER 14CM 5-1/2", WITH LOCK, CONCAVE BLADES (ARTICLE NO.: 74.336.14)

    MDR report key: 9580148 · Received January 13, 2020

    Report

    Report Number
    3002806816-2020-00001
    Event Type
    Injury
    Date Received
    January 13, 2020
    Date of Event
    August 12, 2015
    Report Date
    January 13, 2020
    Manufacturer
    DIMEDA INSTRUMENTE GMBH
    Product Code
    GFA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AT ALL RELEVANT TIMES, (B)(6) WAS A PODIATRIST EMPLOYED AT THE (B)(6) MEDICAL CENTER IN (B)(6). ON (B)(6) 2015, (B)(6) WAS USING THE INSTRUMENT WHILE TREATING A PATIENT AT THE (B)(6) MEDICAL CENTER. DURING THE COURSE OF THE TREATMENT, THE INSTRUMENT SUDDENLY AND UNEXPECTEDLY BROKE APART IN (B)(6) HAND. AS A RESULT OF THE DEFECTIVE NATURE OF THE INSTRUMENT. (B)(6) SUFFERED AN INJURY TO HIS RIGHT HAND, REQUIRING VARIOUS SURGERIES AND RESULTING IN SIGNIFICANT AND PERMANENT PAIN AND DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44933 NAIL NIPPER 14CM 5-1/2", WITH LOCK, CONCAVE BLADES (ARTICLE NO.: 74.336.14) GFA DIMEDA INSTRUMENTE GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| S