FDA Adverse Event
Malfunction
Summary report: N
SYRINGE, PISTON
MDR report key: 22523292
·
Received July 16, 2025
Report
- Report Number
- MW5172786
- Event Type
- Malfunction
- Date Received
- July 16, 2025
- Date of Event
- July 14, 2025
- Report Date
- July 15, 2025
- Manufacturer
- NOVO NORDISK INC.
- Product Code
- FMF
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- GA, US
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
Description of Event or Problem · 0
THE REPORTER STATED THAT WHEN SHE WAS ABOUT TO TAKE OZEMPIC SEMAGLUTIDE INJECTION, THE SYRINGE WAS LEAKING, HENCE SHE COULD NOT TAKE THE MEDICATION. SHE ALSO STATED THAT THIS HAPPENED TWICE WITH HER. PATIENT CODE:4582. DEVICE CODE: 1354. REFERENCE REPORT: MW5172787.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1561377 | SYRINGE, PISTON | SYRINGE, PISTON | FMF | NOVO NORDISK INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Female | OZEMPIC SEMAGLUTIDE INJECTION. |