Device adverse event reports (MAUDE)

OZEMPIC (SEMAGLUTIDE) INJECTION · NEEDLE, HYPODERMIC SINGLE LUMEN

NOVO-NORDISK A/S · Adverse Event Without Identified Device or Use Problem

InjuryInitial submissionMDR 8470233
Event location
NO INFORMATION
Report to FDA
I
Manufacturer link flag
N
Event type
Injury
Report number
MW5085393
Product problem flag
N
Date received
20190329
Date of event
20190325
Reprocessed and reused flag
I
Reporter occupation code
UNKNOWN
Noe summarized
1
Reporter country code
US
Date added
20190401
Reporter state code
MD
Date changed
20250825
Summary report flag
N
Date report
20190326
MDR report key
8470233
Report source code
Voluntary report
Adverse event flag
Y
Type of report
Initial submission
Device
  1. Device sequence number
    260537
    Date received
    20190329
    Brand name
    OZEMPIC (SEMAGLUTIDE) INJECTION
    Generic name
    NEEDLE, HYPODERMIC SINGLE LUMEN
    Manufacturer d name
    NOVO-NORDISK A/S
    Device operator
    LAY USER/PATIENT
    Expiration date of device
    20201231
    Device availability
    No
    Device report product code
    FMI
    Combination product flag
    N
    UDI di
    00076913708748
    UDI public
    076913708748
    Harmonized identifiers (openFDA)
    Device name
    Needle, Hypodermic, Single Lumen
    Medical specialty description
    General Hospital
    Regulation number
    880.5570
    Device class
    2
Product problems
Adverse Event Without Identified Device or Use Problem
Patient
  1. Patient sequence number
    1
    Date received
    20190329
    Patient age
    72 YR
    Patient problems
    Needle Stick/Puncture, Needle Stick/Puncture
MDR text
  1. MDR text key
    140532754
    Text type code
    Description of Event or Problem
    Patient sequence number
    1
    Text

    DURING AN IN-PERSON INTERVIEW, THE PARTICIPANT ACCIDENTALLY STUCK HIMSELF WITH THE OZEMPIC NEEDLE (DEVICE #(B)(4)) WHILE IN THE PROCESS OF REMOVING THE NEEDLE FROM THE PEN. I IMMEDIATELY CALLED THE NURSE TO COME OVER AND SHE DISINFECTED THE INJURY AND PUT A BAND-AID ON IT. THE PARTICIPANT STATED HE WAS FINE AND PROCEEDED WITH THE INTERVIEW. ONCE THE INTERVIEW WAS COMPLETE, I CONFIRMED AGAIN WHETHER THE PARTICIPANT WAS OKAY AND HE RESPONDED THAT HE WAS FINE.

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How to read this: Each report says someone told FDA an event happened while a product was used. A report does not show the product caused it, and counts rise and fall with how many people report. Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.