BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIGIT WIDGET

    MDR report key: 7984991 · Received October 19, 2018

    Report

    Report Number
    2919128-2018-00025
    Event Type
    Injury
    Date Received
    October 19, 2018
    Report Date
    October 20, 2018
    Manufacturer
    HAND BIOMECHANICS LAB, INC.
    Product Code
    JDW
    UDI-DI
    00861994000212
    PMA / PMN Number
    K992970
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    PATIENT HAD SURGERY TO INSTALL A DIGIT WIDGET EXTERNAL FIXATION SYSTEM. AT 3 WEEKS POST OPERATIVE, THE PHYSICIAN REPORTED THAT PATIENT CALLED HIM REGARDING A "MILD REDNESS AROUND THE PROXIMAL PIN". REDNESS WENT AWAY AFTER A 10 DAY TREATMENT WITH ORAL ANTIBIOTICS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PATIENT HAD SURGERY TO INSTALL A DIGIT WIDGET EXTERNAL FIXATION SYSTEM. AT 3 WEEKS POST OPERATIVE, THE PHYSICIAN REPORTED THAT PATIENT CALLED HIM REGARDING A "MILD REDNESS AROUND THE PROXMIAL PIN". REDNESS WENT AWAY AFTER A 10 DAY TREATMENT WITH ORAL ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827920 DIGIT WIDGET DIGIT WIDGET JDW HAND BIOMECHANICS LAB, INC. DWD-232 DWD-118-033A 00861994000212

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention