BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOFINE 32G 6 MM

    MDR report key: 12867173 · Received November 24, 2021

    Report

    Report Number
    9681821-2021-00074
    Event Type
    Injury
    Date Received
    November 24, 2021
    Date of Event
    March 12, 2021
    Report Date
    November 1, 2021
    Manufacturer
    NOVO NORDISK A/S
    Product Code
    FMI
    PMA / PMN Number
    K090111
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CASE DESCRIPTION: INVESTIGATIONAL RESULTS: NAME: NOVOFINE 32G ETW TIP 0.23/0.25*6MM, BATCH NUMBER: 20H04Y THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. NO FURTHER INFORMATION AVAILABLE. SINCE LAST SUBMISSION, THE CASE HAS BEEN UPDATED WITH THE FOLLOWING: -INV UPDATED, -ANNEX B,C,D,G CODES UPDATED IN THE DEVICE TAB -FINAL REPORT CHECKED IN EU/CA DEVICE TAB -IS NON-REPORTABLE SELECTED AS NO -MALFUNCTION UPDATED AS NO -DEVICE NARRATIVE UPDATED -NARRATIVE UPDATED ACCORDINGLY. H3 CONTINUED: EVALUATION SUMMARY NAME: NOVOFINE 32G ETW TIP 0.23/0.25*6MM, BATCH NUMBER: 20H04Y THE PRODUCT WAS NOT RETURNED FOR EXAMINATION.

    Description of Event or Problem · 0

    EVENT VERBATIM [PREFERRED TERM] (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS) LOCAL PAIN DURING INJECTION [INJECTION SITE PAIN] NEEDLE LEAKAGE [DEVICE LEAKAGE] CASE DESCRIPTION: THIS SERIOUS SPONTANEOUS REGULATORY AUTHORITY CASE RECEIVED VIA (B)(6) WAS REPORTED BY A HEALTH CARE PROFESSIONAL NOS AS "LOCAL PAIN DURING INJECTION(PAIN DURING INJECTION)" BEGINNING ON (B)(6) 2021, "NEEDLE LEAKAGE(DEVICE LEAKAGE)" BEGINNING ON (B)(6) 2021, AND CONCERNED A (B)(6) MALE PATIENT WHO WAS TREATED WITH NOVOFINE 32G 6 MM (NEEDLE) FROM UNKNOWN START DATE FOR "DEVICE THERAPY", THE PATIENT'S HEIGHT, WEIGHT AND BODY MASS INDEX WAS NOT REPORTED. DOSAGE REGIMENS: NOVOFINE 32G 6 MM: MEDICAL HISTORY WAS NOT PROVIDED. CONCOMITANT PRODUCTS INCLUDED - INSULIN ON (B)(6) 2021, THE PATIENT HAD TO USE NOVOFINE FOR INSULIN INJECTION. DURING USE, THE PATIENT FELT PAIN AT THE INJECTION SITE, AND THERE WAS NEEDLE LEAKAGE. THE PATIENT WENT TO THE HOSPITAL FOR INQUIRIES. THE CAUSE COULD NOT BE DETERMINED FOR THE TIME BEING, AND THE HOSPITAL CHANGED THE STERILE HYPODERMIC NEEDLES FOR SINGLE USE FOR THE PATIENT. BATCH NUMBERS: NOVOFINE 32G 6 MM: 20H04Y. ACTION TAKEN TO NOVOFINE 32G 6 MM WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "LOCAL PAIN DURING INJECTION(PAIN DURING INJECTION)" WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "NEEDLE LEAKAGE(DEVICE LEAKAGE)" WAS NOT REPORTED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1764875 NOVOFINE 32G 6 MM NEEDLE FMI NOVO NORDISK A/S N/A 20H04Y

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Other INSULIN (INSULIN)