FDA Adverse Event
Malfunction
Summary report: N
OPTUNE GIO
MDR report key: 21923808
·
Received April 29, 2025
Report
- Report Number
- 3010457505-2025-00499
- Event Type
- Malfunction
- Date Received
- April 29, 2025
- Date of Event
- April 5, 2025
- Report Date
- April 29, 2025
- Manufacturer
- NOVOCURE GMBH
- Product Code
- NZK
- UDI-DI
- 07290107982238
- PMA / PMN Number
- P100034
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
NOVOCURE MEDICAL OPINION IS THAT THE CONTRIBUTION OF THE ARRAY PLACEMENT TO THE SKIN IRRITATION CANNOT BE RULED OUT. MEDICAL DEVICE SITE REACTION IS AN EXPECTED EVENT WITH OPTUNE GIO DEVICE USE (EF-11 16% AND 53% EF-14 OPTUNE ARM). ADDITIONAL NOTE: MANUFACTURER DATE OF (B)(6) IS MARCH 3, 2019.
Description of Event or Problem · 0
A 66-YEAR-OLD MALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY ON (B)(6) 2024. ON (B)(6) 2025, NOVOCURE WAS INFORMED THAT THE PATIENT EXPERIENCED SKIN IRRITATION ASSOCIATED WITH OPTUNE GIO THERAPY. REPORTEDLY, THE DERMATOLOGIST WAS UNABLE TO PRESCRIBE STRONGER MEDICATION THAN STEROIDS. THE PATIENT CONTINUED OPTUNE GIO THERAPY DESPITE THE IRRITATION. NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE PRESCRIBING PHYSICIAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 480951 | OPTUNE GIO | OPTUNE GIO | NZK | NOVOCURE GMBH | TFH9100 | 07290107982238 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Male | Required Intervention | NOT PROVIDED. |