BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGANTURE SERIES PREFILL, 10% NBF 120ML BIO 75/CASE

    MDR report key: 9219024 · Received October 22, 2019

    Report

    Report Number
    1831638-2019-00005
    Event Type
    Injury
    Date Received
    October 22, 2019
    Date of Event
    August 9, 2017
    Report Date
    October 22, 2019
    Manufacturer
    RICHARD ALLAN SCIENTIFIC
    Product Code
    IFP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PLANTIFF ALLEGES THAT ON OR ABOUT (B)(6) 2017, SHE WAS INJURED WHEN SHE OPENED AN UNMARKED BOX CONTAINING A BAG WITH "BROKEN CONTAINERS" CONTAINING AND "UNKNOWN CHEMICAL". AS SHE OPENED THE BAG, SHE SAW THE BROKEN CONTAINERS AND INHALED THE UNKNOWN CHEMICAL, ALLEGEDLY CAUSING HER INJURY. SHE CLAIMS UNSPECIFIED BODILY INJURIES, MEDICAL EXPENSES, LOST EARNINGS, AND PAIN AND SUFFERING. PLAINTEFF ALLEGES THAT DEFENDANTS FAILED TO PROPERLY HANDLE AND PROPERLY LABEL THE BOX, WHICH THEY HAD PREVIOUSLY HANDLED/TRANSPORTED. RESPIRATORY IMPACT WAS THE ONLY INJURY NOTED IN THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016218 SIGANTURE SERIES PREFILL, 10% NBF 120ML BIO 75/CASE 10% FORMALIN IFP RICHARD ALLAN SCIENTIFIC 561201 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other