BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C4D (SP91)

    MDR report key: 7975541 · Received October 17, 2018

    Report

    Report Number
    1649339-2018-00001
    Event Type
    Injury
    Date Received
    October 17, 2018
    Date of Event
    February 19, 2018
    Report Date
    March 15, 2018
    Manufacturer
    CELL MARQUE CORPORATION
    Product Code
    NJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED RETROSPECTIVELY PER FDA REQUEST. PATIENT CODE: 2688 IN 2018 AND HAS SINCE BEEN UPDATED PER FDA. METHOD CODE: 3323 IN 2018 AND SINCE HAS BEEN UPDATED TO 4111 PER FDA.

    Description of Event or Problem · 0

    ON 2/19/2018, A CALL WAS RECEIVED FROM THE UNIVERSITY OF PENN DIRECTOR OF OCCUPATIONAL MEDICINE DR. (B)(6). SHE CALLED TO REPORT THAT SEVEN PATIENTS (6 FEMALES AND 1 MALE) AND EMPLOYEES OF THE HOSPITAL, CAME IN TO HAVE AN ANNUAL TB SCREENING. ALL SEVEN PATIENTS WERE INJECTED WITH C4D (SP91) RABBIT POLYCLONAL ANTIBODY, PREDILUTE IN A LEICA BOND DISPENSER. THE NURSE PRACTITIONER ASSUMED SHE WAS INJECTING TUBERCULIN PURIFIED PROTEIN DERIVATIVE ALSO KNOW AS TUBERSOL USED IN THE TESTING FOR TB. POST INJECTION SIX OF THE PATIENTS EXPERIENCED THE FOLLOWING PHYSIOLOGICAL SYMPTOMS: - FIVE OF THE SEVEN PATIENTS EXPERIENCE HEADACHES, - TWO PATIENTS HAD AN ALLERGIC REACTION, - ONE OF THE TWO PATIENTS EXPERIENCED A DELAYED HEADACHED AND DEVELOPED A RASH. THE PERSON WITH THE DELAYED REACTION HAD A SEVERE HEADACHE WITH JOINT PAIN AT THE INJECTION SITE. THE PATIENT WAS GIVEN A STEROID AND A ANTIHISTAMINE AS WELL AS A CT SCAN. THE ERROR WAS DISCOVERED WITHIN 2 HOURS OF INJECTION. AT THE TREATING PHYSICIAN'S REQUEST AND ADVICE OF THE EH&S OFFICER, THE SAFETY DATA SHEET (SDS) DOCUMENTS FOR THE ANTIBODY, SODIUM AZIDE AND BOVINE SERUM WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817158 C4D (SP91) RABBIT MONOCLONAL PRIMARY ANTIBODY NJT CELL MARQUE CORPORATION PA0792 52743

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention