BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIGIT WIDGET

    MDR report key: 7113180 · Received December 13, 2017

    Report

    Report Number
    2919128-2017-00002
    Event Type
    Injury
    Date Received
    December 13, 2017
    Date of Event
    June 19, 2015
    Report Date
    December 27, 2018
    Manufacturer
    HAND BIOMECHANICS LAB, INC
    Product Code
    JDW
    PMA / PMN Number
    K992970
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEWED STERILIZATION AND STERILE BARRIER INSPECTION RECORDS OF LOT. NO PATTERN RELATED TO IRRADIATION DOSE LOT OR DEVICE LOT 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. PATIENT REPORTED 35 DAYS POST OPERATIVE THAT PHYSICIAN WAS TREATING PIN SITE INFECTION WITH ANTIBIOTIC.

    Additional Manufacturer Narrative · 1

    REVIEWED STERILIZATION AND STERILE BARRIER INSPECTION RECORDS OF LOT. NO PATTERN RELATED TO IRRADIATION DOSE LOT OR DEVICE LOT NOTED. CONFIRMED LABELING INCLUDED CAUTIONS REGARDING PIN SITE CARE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT PATIENT HAD SURGERY TO INSTALL A DIGIT WIDGET TO STRAIGHTEN A FLEXION CONTRACTURE. PATIENT REPORTED 35 DAYS POST OPERATIVE THAT PHYSICIAN WAS TREATING PIN SITE INFECTION WITH ANTIBIOTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892094 DIGIT WIDGET DIGIT WIDGET JDW HAND BIOMECHANICS LAB, INC DWD-232 DWD-114-063B

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention