BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNI-PUNCH

    MDR report key: 9673222 · Received February 5, 2020

    Report

    Report Number
    0002521453-2020-00001
    Event Type
    Malfunction
    Date Received
    February 5, 2020
    Date of Event
    January 13, 2020
    Report Date
    February 3, 2020
    Manufacturer
    PREMIER DENTAL PRODUCTS CO. DBA PREMIER MEDICAL
    Product Code
    LRY
    PMA / PMN Number
    K896303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    BIOPSY PUNCH LEFT A DARK RESIDUE ON PATIENT'S SKIN POST PROCEDURE. BIOPSY PUNCHES ARE DELIVERED STERILE AND NO HARM TO PATIENT REPORTED.

    Description of Event or Problem · 1

    BIOPSY PUNCH LEFT A DARK RESIDUE ON PATIENT'S SKIN POST PROCEDURE. BIOPSY PUNCHES ARE DELIVERED STERILE AND NO HARM TO PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137682 UNI-PUNCH BIOPSY PUNCH LRY PREMIER DENTAL PRODUCTS CO. DBA PREMIER MEDICAL P17030680

    Patients

    Seq Age Sex Outcome Treatment
    1 Other