Device adverse event reports (MAUDE)

WEGOVY (SEMAGLUTIDE) 2.4MG SINGLE DOSE PRE-FILLED PEN · INJECTOR, PEN

UNK · Failure to Eject

MalfunctionInitial submissionMDR 17052477
Manufacturer link flag
N
Event type
Malfunction
Report number
MW5118089
Product problem flag
Y
Date received
20230601
Date of event
20230531
Reporter occupation code
PATIENT
Noe summarized
1
Reporter country code
US
Date added
20230605
Reporter state code
NC
Date changed
20250724
Health professional
N
Summary report flag
N
Date report
20230601
MDR report key
17052477
Report source code
Voluntary report
Adverse event flag
N
Type of report
Initial submission
Device
  1. Device sequence number
    33925
    Date received
    20230601
    Brand name
    WEGOVY (SEMAGLUTIDE) 2.4MG SINGLE DOSE PRE-FILLED PEN
    Generic name
    INJECTOR, PEN
    Manufacturer d name
    UNK
    Manufacturer d address 1
    UNK
    Manufacturer d city
    UNK
    Device operator
    LAY USER/PATIENT
    Expiration date of device
    20240430
    Lot number
    MZF3F99
    Device availability
    No answer provided
    Device report product code
    NSC
    Combination product flag
    Y
    Harmonized identifiers (openFDA)
    Device name
    Injector, Pen
    Medical specialty description
    General Hospital
    Regulation number
    880.5860
    Device class
    2
Product problems
Failure to Eject
Patient
  1. Patient sequence number
    1
    Date received
    20230601
    Patient age
    67 YR
    Patient sex
    Female
    Patient problems
    Insufficient Information, Insufficient Information
MDR text
  1. MDR text key
    316503803
    Text type code
    Description of Event or Problem
    Patient sequence number
    0
    Text

    REPORTER CALLING, STATING THAT HER INJECTION PEN MALFUNCTIONED. SHE STATES THAT THE NEEDLE WOULD NOT GO INTO HER LEG, AND AS A RESULT THE MEDICATION ENDED UP ON THE OUTSIDE OF HER LEG INSTEAD OF BEING INJECTED INTO HER LEG AS INTENDED. REPORTER STATES SHE NEEDS A REPLACEMENT BECAUSE SHE DID NOT RECEIVE HER MEDICATION.

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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.