BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIGIT WIDGET

    MDR report key: 16857680 · Received May 2, 2023

    Report

    Report Number
    2919128-2023-00003
    Event Type
    Injury
    Date Received
    May 2, 2023
    Date of Event
    April 26, 2023
    Report Date
    April 28, 2023
    Manufacturer
    HAND BIOMECHANICS LAB, INC
    Product Code
    JDW
    PMA / PMN Number
    K992970
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYZED PRODUCTION RECORDS, PERFORMED HISTORICAL DATA ANALYSIS AND TREND ANALYSIS. NO TREND RELATE TO IRRADIATION DOSE LOT OR DEVICE LOT WAS NOTED. LABELING INCLUDED CAUTIONS REGARDING PIN SITE CARE.

    Description of Event or Problem · 0

    ON 4/26/23, (B)(6) INQUIRED IF HBL HAS ANY PATIENT-RELATED VIDEOS THAT COULD ASSIST (B)(6) PATIENT BW WHO IS HAVING DIFFICULTY USING THE DIGIT WIDGET. (B)(6) FURTHER ADDED THAT THE PATIENT BW WAS TREATED FOR A POSSIBLE INFECTION WITH ORAL ANTIBIOTICS AND THAT DR. WEISS DID NOT INTEND TO REMOVE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1826980 DIGIT WIDGET DIGIT WIDGET JDW HAND BIOMECHANICS LAB, INC DWD-232 DWD-122-132B

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention