BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIGIT WIDGET

    MDR report key: 7113231 · Received December 13, 2017

    Report

    Report Number
    2919128-2017-00006
    Event Type
    Injury
    Date Received
    December 13, 2017
    Report Date
    December 27, 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

    DETERMINED EVENT FROM 1 OF 2 POSSIBLE DEVICES. REVIEWED STERILIZATION AND STERILE BARRIER INSPECTION RECORDS OF BOTH LOTS. NO PATTERN RELATED TO IRRADIATION DOSE LOT OR DEVICE LOT WAS NOTED. CONFIRMED LABELING INCLUDED CAUTIONS REGARDING PIN SITE CARE.

    Description of Event or Problem · 0

    IT IS REPORTED THAT PATIENT HAD SURGERY TO INSTALL A DIGIT WIDGET TO STRAIGHTEN A FLEXION CONTRACTURE. PHYSICIAN REPORTED, "PATIENT DEVELOPED PIN SIT INFECTION AFTER 7 WEEKS AND I REMOVED THE PINS".

    Additional Manufacturer Narrative · 1

    DETERMINED EVENT FROM 1 OF 2 POSSIBLE DEVICES. REVIEWED STERILIZATION AND STERILE BARRIER INSPECTION RECORDS OF BOTH LOTS. NO PATTERN RELATED TO IRRADIATION DOSE LOT OR DEVICE LOT WAS NOTED. CONFIRMED LABELING INCLUDED CAUTIONS REGARDING PIN ISTE CARE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT PATIENT HAD SURGERY TO INSTALL A DIGIT WIDGET TO STRAIGHTEN A FLEXION CONTRACTURE. PHYSICIAN REPORTED, "PATIENT DEVELOPED PIN SIT INFECTION AFTER 7 WEEKS AND I REMOVED THE PINS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893174 DIGIT WIDGET DIGIT WIDGET JDW HAND BIOMECHANICS LAB, INC. DWD-232 00861994000212

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention