Optune Gio TFH9100Recalls & reported problems

Summary

The FDA's MAUDE database contains 153 adverse event reports that list this exact device (DI 07290107986427), received between Oct 18, 2024 and Sep 29, 2026 — classified as 153 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 153 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Wound Dehiscence

  MAUDE report 50930454 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  A 41-year-old male patient with newly diagnosed glioblastoma (GBM) started Optune Gio therapy on (b)(6) 2026. On (b)(6) 2026, the patient informed Novocure that he had been hospitalized due to headaches. On (b)(6) 2026, a follow-up report was received indicating that the patient had temporarily discontinued Optune Gio therapy due to headaches, nightmares, and hallucinations. On (b)(6) 2026, the patient further confirmed that he had resumed Optune Gio therapy approximately one week earlier and that the treatment interruption had been due to headaches experienced while on therapy; however, the headaches had been resolved by the time of the report. Review of the available medical records revealed a medical history significant for localization-related epilepsy, mild traumatic brain injury, alcohol abuse, and headaches associated with altitude changes, all predating the initiation of Optune Gio therapy. The patient also reported a history of a motor vehicle accident at the age of 19, after which he experienced chronic sleep disturbances. Multiple attempts were made to contact the prescribing physician; however, no reply was received.

  Patient problems: Headache

  MAUDE report 50867607 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Laceration(s)

  MAUDE report 50818974 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  A 52-year-old male patient with newly diagnosed glioblastoma (GBM) started Optune Gio therapy on (b)(6) 2024. On (b)(6) 2026, the patient's spouse informed Novocure that the patient had temporarily discontinued Optune Gio therapy on (b)(6) 2026, due to non-healing scalp lesions. The spouse stated that the infusion therapy was preventing the patient's scalp from adequately recovering and healing. Photographs provided showed both the left and right sides of the patient's scalp. Multiple moderately erythematous ulcerations and lesions were noted on the superior and left lateral scalp. An escharred ulceration was observed on the left scalp above the surgical resection site. Additionally, a small wound dehiscence with yellow exudate was present along the surgical incision. Multiple attempts were made to contact the prescribing physician for further information; however, no response has been received to date.

  Patient problems: Wound Dehiscence

  MAUDE report 50767571 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  A 63-year-old female with newly diagnosed glioblastoma (GBM) started Optune Gio therapy on (b)(6), 2026. On August 21, 2026, Novocure received a medical record dated August 17, 2026, indicating that the patient experienced scalp irritation and itching and was prescribed hydroxyzine. The medication was also recommended to use for nighttime anxiety related to potential progression of underlying disease. On (b)(6), 2026, the prescribing physician confirmed that the patient experienced skin irritation related to Optune Gio arrays. The patient was treated with hydroxyzine, which resolved the event, and continued Optune Gio therapy. According to the physician, the patient was not taking any medications that could have been considered a risk factor for skin irritation.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 50767449 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  A 39-year-old male patient with newly diagnosed glioblastoma (GBM) started Optune Gio therapy on (b)(6) 2026. On (b)(6) 2026, Novocure received a medical record dated (b)(6) 2026, indicating that the patient was experiencing mild irritation at the surgical incision site, which remained slightly open. During a follow up appointment on (b)(6) 2026, it was noted that the patient tolerated Optune Gio well without skin side effects. An attempt was made to contact the prescribing physician; however, no reply was received.

  Patient problems: Wound Dehiscence

  MAUDE report 50767402 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  A 37-year-old male patient with newly diagnosed glioblastoma (GBM) started Optune Gio therapy on (b)(6), 2026. On (b)(6) 2026, the patient informed Novocure that he had experienced a burning sensation on his scalp while lying down. Later that night, the patient experienced the same sensation again beneath the right array. On (b)(6), 2026, the patient noticed a small, round burn-like lesion on the right occipital area of the scalp. A provided photograph depicted the back of the patient's scalp with a small, circular, moderately erythematous lesion accompanied by scaling of the surrounding skin. The patient temporarily discontinued Optune Gio therapy. On August 17, 2026, additional information was received indicating that the patient had been prescribed topical mupirocin and oral amoxicillin, which were initiated on (b)(6), 2026. The treating physician advised the patient to continue the treatment interruption until the skin lesion had completely healed. Attempts were made to contact the prescribing physician; however, no reply was received.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 50749770 ↗
• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  A 63-year-old female patient with newly diagnosed glioblastoma (GBM) began Optune Gio therapy on (b)(6) 2026. On (b)(6) 2026, the patient's daughter informed Novocure that the patient had temporarily discontinued Optune Gio therapy the previous day due to a wound described as a small scab with an underlying fluid collection at the surgical incision site. On August 17, 2026, additional information was received indicating that the surgical incision had become infected. The patient was treated with unspecified antibiotics and temporarily discontinued Optune Gio therapy following the recommendation of the healthcare provider. On (b)(6) 2026, Novocure received a medical record dated (b)(6) 2026, indicating that the patient had completed a one-week course of amoxicillin and doxycycline for drainage from the surgical site. At the time of the appointment, yellow drainage was still present; however, it had improved, and the patient was applying bacitracin and using bandages. The patient's family reported that the patient frequently touched the wound. Additionally, temozolomide therapy had been temporarily discontinued to support wound healing. Multiple attempts were made to contact the pres

  Patient problems: Post Operative Wound Infection

  MAUDE report 50712596 ↗
• InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem

  A 71-year-old female with recurrent glioblastoma (GBM) started Optune Gio therapy on (b)(6)2025. On (b)(6) 2026, Novocure received a medical record dated (b)(6)2026, indicating that the patient experienced intermittent scalp irritation with small, painful sores. The patient reported having two scalp cysts removed by a dermatologist. Although the nodules appeared similar to those previously experienced, the patient's family reported improvement in the scalp condition. The patient was prescribed topical clobetasol. On (b)(6)2026, persistent scalp issues, including raised nodules and sores, were reported, particularly on the posterior and superior scalp, and were aggravated by Optune Gio use. Due to pain and skin breakdown, the patient temporarily discontinued Optune Gio therapy. Skin peeling following array removal and erythematous lesions beneath the arrays were also reported. During a follow-up visit on (b)(6) 2026, the patient attributed the scalp issues to head shaving and reported some improvement with mometasone cream; however, the bumps persisted. Continuation of Optune Gio therapy was advised. On (b)(6) 2026, the patient continued to experience scalp cysts. The dermatologist

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 50446352 ↗
• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  On August 19, 2026, Novocure received a response from the HCP indicating that the patient was not hospitalized and did not require any treatment for the reported event. According to the physician, there were no signs of wound dehiscence or infection. The physician further assessed that the event was not related to Optune Gio therapy, and the patient continued treatment.

  Patient problems: Wound Dehiscence

  MAUDE report 50155879 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  A 72-year-old female patient with newly diagnosed glioblastoma (GBM) initiated Optune Gio therapy on (b)(6), 2023. On June 10, 2026, Novocure was informed that the patient developed scalp skin irritation, described as a contusion or indentation on the side of the head. As a result, Optune Gio therapy was temporarily discontinued. The provided image demonstrated purulent drainage with moderate erythema at the patient¿s surgical resection site above the left ear. On June 29, 2026, the patient reported that, due to the skin irritation, she had not used the therapy from (b)(6) through (b)(6), 2026. Following resumption of Optune Gio therapy from (b)(6) through (b)(6), 2026, the irritation recurred. A physician prescribed topical clobetasol propionate cream, and the patient rotated the arrays in an attempt to reduce further irritation. An additional photograph of the same area demonstrated a wound dehiscence at the superior aspect of the surgical resection site, accompanied by mild erythema. On (b)(6), 2026, the patient reported upon removing the arrays that day, she observed a large sore along the surgical resection site. The patient confirmed that she had been rotating the arrays and

  Patient problems: Wound Dehiscence

  MAUDE report 50033757 ↗
• InjuryJul 2, 2026Adverse Event Without Identified Device or Use Problem

  A 52-YEAR-OLD MALE WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO (B)(6) 2025. ON (B)(6) 2026, THE PATIENT INFORMED NOVOCURE THAT HE EXPERIENCED REDNESS AND OPEN SORES ON THE SCALP. THE PATIENT WAS PRESCRIBED A TEN-DAY COURSE OF ORAL CEPHALEXIN AND ADVISED TO TEMPORARILY DISCONTINUE OPTUNE GIO THERAPY. IN AN AVAILABLE MEDICAL RECORD, DURING A NEURO-ONCOLOGY FOLLOW UP VISIT ON (B)(6) 2026, THE PHYSICIAN DOCUMENTED THAT THE PATIENT HAD AN OPEN WOUND AND SCALP IRRITATION, WITH DRAINAGE SECONDARY TO OPTUNE DEVICE USE. THE PHYSICIAN PRESCRIBED CEPHALEXIN 500MG FOUR TIMES DAILY FOR TEN DAYS MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE PRESCRIBING PHYSICIAN; HOWEVER, NO REPLY WAS RECEIVED.

  Patient problems: Skin Infection; Skin Inflammation/ Irritation

  MAUDE report 25687272 ↗
• InjuryJul 2, 2026Adverse Event Without Identified Device or Use Problem

  A 73-YEAR-OLD MALE WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO (B)(6) 2023. ON (B)(6) 2026, NOVOCURE RECEIVED A MEDICAL RECORD DATED (B)(6) 2026, INDICATING THAT THE PATIENT EXPERIENCED SKIN IRRITATION AND INTERMITTENT SCALP PRURITUS SECONDARY TO OPTUNE GIO DEVICE USE. THE PATIENT WAS PRESCRIBED DOXYCYCLINE 100 MG DAILY AND ADVISED TO TEMPORARILY DISCONTINUE OPTUNE GIO THERAPY. PATIENT SUBSEQUENTLY REPORTED INTERVAL IMPROVEMENT AND RESUMED OPTUNE GIO. ON (B)(6) 2026, THE PRESCRIBING PHYSICIAN CONFIRMED THAT THE PATIENT RECEIVED ORAL ANTIBIOTIC DOXYCYCLINE AS AN OUTPATIENT. THE TRANSDUCER ARRAYS HAD BEEN SHIFTED AND THE SKIN CONDITION IMPROVED. THE PATIENT HAD SINCE RESUMED OPTUNE GIO THERAPY.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 25687267 ↗
• InjuryJul 2, 2026Adverse Event Without Identified Device or Use Problem

  AN (B)(6) -YEAR-OLD MALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) BEGAN OPTUNE GIO THERAPY ON (B)(6) 2025. ON (B)(6) 2026, NOVOCURE RECEIVED A MEDICAL RECORD DATED MARCH 11, 2026, INDICATING THAT THE PATIENT DEVELOPED PAINFUL SCALP SORES, INCLUDING ONE PARTICULARLY PAINFUL LESION, AND TEMPORARILY DISCONTINUED OPTUNE GIO THERAPY ON (B)(6) 2026, TO ALLOW THE SCALP TO HEAL. PHYSICAL EXAMINATION REVEALED A SMALL PUSTULAR LESION NEAR THE LEFT TEMPLE AND SEVERAL SUPERFICIAL SCALP ABRASIONS WITHOUT PUSTULAR DRAINAGE. TO MANAGE A SUPERFICIAL SKIN INFECTION, THE PATIENT WAS PRESCRIBED CLOBETASOL CREAM AND CEPHALEXIN AND WAS ADVISED TO REMAIN OFF THERAPY UNTIL THE SCALP HAD HEALED. DURING A FOLLOW UP APPOINTMENT ON (B)(6) 2026, IT WAS NOTED THAT THE SCALP HEALED. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE PRESCRIBING PHYSICIAN; HOWEVER, NO REPLY WAS RECEIVED.

  Patient problems: Skin Infection

  MAUDE report 25687139 ↗
• InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem

  A 62-YEAR-OLD MALE WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY ON (B)(6) 2024. ON (B)(6) 2026, NOVOCURE WAS INFORMED THAT THE PATIENT DEVELOPED A BLISTER ON THE TOP OF THE SCALP AND AN ERYTHEMATOUS RASH ON THE RIGHT SIDE OF THE HEAD. THE PATIENT PLANNED TO TREAT THESE ISSUES WITH ORAL CLINDAMYCIN AND CLOBETASOL GEL, AS PRESCRIBED BY A HEALTHCARE PROVIDER. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE PRESCRIBING PHYSICIAN; HOWEVER, NO REPLY WAS RECEIVED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 25665182 ↗
• InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem

  A 68-YEAR-OLD FEMALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) BEGAN OPTUNE GIO THERAPY ON (B)(6) 2025. ON (B)(6) 2026, THE PATIENT¿S DAUGHTER INFORMED NOVOCURE THAT THE PATIENT DEVELOPED A SKIN INFECTION ABOVE BOTH EARS AND WAS PRESCRIBED SULFAMETHOXAZOLE/TRIMETHOPRIM WHICH RESOLVED THE ISSUE. DUE TO THE INFECTION, THE PATIENT TEMPORARILY DISCONTINUED OPTUNE GIO THERAPY BETWEEN ON (B)(6) 2026. THE REPORTER NOTED THAT IN THEIR OPINION, THE TRANSDUCER ARRAYS DID NOT CONTRIBUTE TO THE EVENT. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE PRESCRIBING PHYSICIAN; HOWEVER, NO REPLY WAS RECEIVED.

  Patient problems: Skin Infection

  MAUDE report 25634520 ↗
• InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem

  A 67-YEAR-OLD FEMALE WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM), STARTED OPTUNE GIO THERAPY ON (B)(6) 2025. ON (B)(6) 2026, THE PATIENT'S SPOUSE INFORMED NOVOCURE THAT THE PATIENT EXPERIENCED AN UNWITNESSED FALL ON (B)(6) 2026, WHILE ATTEMPTING TO GET OUT OF BED. THE SPOUSE NOTED THAT THE PATIENT WAS NOT WEARING HER NON-SLIP SOCKS, CAUSING HER FEET TO SLIP RESULTING IN A FALL. THE PATIENT STRUCK HER HEAD ON A HEADBOARD, SUSTAINING A FOREHEAD LACERATION. SHE WAS TRANSPORTED TO THE EMERGENCY DEPARTMENT (ED) AND WAS SUBSEQUENTLY ADMITTED TO THE INTENSIVE CARE UNIT (ICU) ON (B)(6) 2026 AND DISCHARGED ON (B)(6) 2026. OPTUNE GIO THERAPY WAS TEMPORARILY DISCONTINUED. ACCORDING TO THE PATIENT, SHE HAD RISEN FROM BED WHILE WEARING THE TRANSDUCER ARRAYS ON THE SCALP, DISCONNECTED FROM THE DEVICE, AND TRIPPED OVER THE DEVICE CONNECTOR CABLE. ON (B)(6) 2026, THE PRESCRIBING PHYSICIAN REPORTED THAT THE PATIENT EXPERIENCED AN ACCIDENTAL FALL AFTER TRIPPING. THE PATIENT SUSTAINED A SMALL AREA OF SKIN BRUISING, AND OPTUNE GIO THERAPY WAS RESUMED WITH TRANSDUCER ARRAY REPOSITIONING. THE PRESCRIBER ALSO NOTED THAT THE PATIENT HAD BEEN EVALUATED AT AN OUTSIDE HOSPITAL; HOWEVER, THE PHYSICIAN HAD NOT PER

  Patient problems: Bruise/Contusion; Fall; Laceration(s)

  MAUDE report 25634466 ↗
• InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem

  A 39-YEAR-OLD MALE WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY ON (B)(6) 2025. ON JUNE 01, 2026, NOVOCURE RECEIVED A MEDICAL RECORD DATED (B)(6) 2026, INDICATING THAT OPTUNE GIO THERAPY EXACERBATED THE PATIENT¿S ONGOING HEADACHES. THE PATIENT USED RIMEGEPANT PRESCRIBED BY A PRIMARY CARE PHYSICIAN AND OXYCODONE-ACETAMINOPHEN TO MANAGE THE SYMPTOMS. IT WAS NOTED THAT THE PATIENT EXPERIENCED SEVERE HEADACHES REQUIRING EMERGENCY DEPARTMENT VISITS PRIOR TO HIS GLIOBLASTOMA (GBM) DIAGNOSIS. DURING AN APPOINTMENT ON (B)(6) 2025, THE PATIENT REPORTED WORSENING HEADACHES AND WAS PRESCRIBED DEXAMETHASONE 4 MG DAILY FOR FIVE TO SEVEN DAYS AND RENEWED THE PATIENT'S SUMATRIPTAN PRESCRIPTION. NO RELATIONSHIP TO OPTUNE GIO THERAPY WAS NOTICED AT THAT TIME. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE PRESCRIBING PHYSICIAN; HOWEVER, NO REPLY WAS RECEIVED.

  Patient problems: Headache

  MAUDE report 25632592 ↗
• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  A 69-YEAR-OLD FEMALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) BEGAN OPTUNE GIO THERAPY ON (B)(6) 2023. ON (B)(6) 2026, NOVOCURE RECEIVED A MEDICAL RECORD DATED ON (B)(6) 2026, INDICATING THAT THE PATIENT CONTINUED TO USE OPTUNE GIO REGULARLY BUT EXPERIENCED SKIN IRRITATION. THE RECORD NOTED THAT THE PATIENT WAS USING A PROTECTIVE BARRIER PRODUCT AND PRESCRIBED HYDROXYZINE 10 MG TO MANAGE ITCHING, AS WELL AS CLOBETASOL 0.05% AND MUPIROCIN 2% OINTMENTS. THE HEALTHCARE PROVIDER ALSO RECOMMENDED INTERMITTENT PERIODS OF SCALP REST. ON JUNE 08, 2026, THE PRESCRIBING PHYSICIAN REPORTED THEY WERE NOT AWARE OF THE REPORTED ISSUE.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 25577014 ↗
• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  A 42-YEAR-OLD FEMALE WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY ON (B)(6) 2024. ON MAY 27, 2026, NOVOCURE RECEIVED A MEDICAL RECORD DATED (B)(6) 2026, REPORTING THAT THE PATIENT EXPERIENCED MILD HEADACHES THAT WERE RESOLVED WHEN NOT USING THE OPTUNE GIO DEVICE. DURING A FOLLOW-UP VISIT ON (B)(6) 2026, THE PATIENT REPORTED TAKING ACETAMINOPHEN SEVERAL TIMES PER DAY, ALTERNATING WITH IBUPROFEN, FOR HEADACHES THAT SHE ATTRIBUTED TO CONTINUOUS OPTUNE GIO USE. THE PHYSICIAN SUBSEQUENTLY PRESCRIBED BUTALBITAL/ACETAMINOPHEN/CAFFEINE 50 MG/325 MG/40 MG TO MANAGE THE HEADACHES AND REDUCE THE PATIENT'S ACETAMINOPHEN INTAKE. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE PRESCRIBING PHYSICIAN; HOWEVER, NO REPLY WAS RECEIVED.

  Patient problems: Headache

  MAUDE report 25576730 ↗
• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  A 57-YEAR-OLD FEMALE WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM), STARTED OPTUNE GIO ON (B)(6) 2026. ON (B)(6) 2026, NOVOCURE RECEIVED A MEDICAL RECORD INDICATING THAT THE PATIENT EXPERIENCED ONGOING HEADACHES, WHICH PREDATED THE INITIATION OF OPTUNE GIO THERAPY. DURING AN APPOINTMENT ON (B)(6) 2026, IT WAS NOTED THAT THE PATIENT WAS TAKING SUMATRIPTAN DAILY WITH SLIGHT BENEFIT. BY (B)(6) 2026, TREATMENT WITH RIMEGEPANT AND BEVACIZUMAB HAD BEEN INITIATED, RESULTING IN IMPROVEMENT, AND THE HEADACHES HAD SIGNIFICANTLY IMPROVED BY (B)(6) 2026. ON (B)(6) 2026, THE PATIENT REPORTED ONLY MINIMAL HEADACHES. DURING A FOLLOW-UP VISIT ON (B)(6) 2026, THE HEADACHES WERE NOTED TO BE IMPROVED AND WERE TYPICALLY ASSOCIATED WITH OPTUNE GIO USE. THE PATIENT USED RIMEGEPANT APPROXIMATELY ONCE WEEKLY TO MANAGE THE SYMPTOMS. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE PRESCRIBING PHYSICIAN; HOWEVER, NO REPLY WAS RECEIVED.

  Patient problems: Headache

  MAUDE report 25576691 ↗
• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  A 72-YEAR-OLD MALE WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY ON (B)(6) 2025. ON MAY 25, 2026, THE PATIENT'S SPOUSE INFORMED NOVOCURE THAT THE PATIENT EXPERIENCED A FALL ON (B)(6) 2026, WHILE ON OPTUNE GIO THERAPY, RESULTING IN A SCALP LACERATION. THE PATIENT WAS EVALUATED IN THE EMERGENCY ROOM (ER) WHERE THE LACERATION WAS TREATED AND CLOSED WITH STAPLES. OPTUNE GIO THERAPY WAS TEMPORARILY DISCONTINUED. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE PRESCRIBING PHYSICIAN; HOWEVER, NO REPLY WAS RECEIVED.

  Patient problems: Laceration(s)

  MAUDE report 25576551 ↗
• InjuryJun 15, 2026Adverse Event Without Identified Device or Use Problem

  A 74-YEAR-OLD FEMALE WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY ON (B)(6) 2026. ON (B)(6) 2026, NOVOCURE RECEIVED A MEDICAL RECORD DATED (B)(6) 2026, INDICATING THAT THE PATIENT EXPERIENCED A WOUND DEHISCENCE. BASED ON THE AVAILABLE INFORMATION, IT WAS UNCLEAR WHETHER THE EVENT WAS CAUSED BY TRAUMA RELATED TO THE TRANSDUCER ARRAYS REMOVAL OR ASSOCIATED WITH BEVACIZUMAB. THE DERMATOLOGIST REPORTEDLY SUSPECTED THE FORMER. THE PATIENT APPLIED BACITRACIN TO THE WOUND AS RECOMMENDED BY A DERMATOLOGIST AND REPOSITIONED THE ARRAYS TO AVOID THE IRRITATED AREA. AN ATTEMPT WAS MADE TO CONTACT THE PRESCRIBING PHYSICIAN; HOWEVER, NO REPLY WAS RECEIVED.

  Patient problems: Wound Dehiscence

  MAUDE report 25503842 ↗
• InjuryJun 15, 2026Adverse Event Without Identified Device or Use Problem

  A 56-YEAR-OLD FEMALE WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO (B)(6) 2026. ON (B)(6) 2026, THE PATIENT¿S CAREGIVER INFORMED NOVOCURE THAT THE PATIENT HAD BEEN ADMITTED TO THE HOSPITAL ON (B)(6) 2026, DUE TO A SURGICAL RESECTION SITE INFECTION REQUIRING A SURGICAL PROCEDURE FOR INFECTION DEBRIDEMENT. THE PATIENT WAS EXPECTED TO REMAIN HOSPITALIZED FOR AN ADDITIONAL THREE DAYS AND TEMPORARILY DISCONTINUED OPTUNE GIO THERAPY UNTIL REMOVAL OF THE POST-SURGICAL SUTURES. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE PRESCRIBING PHYSICIAN; HOWEVER, NO REPLY WAS RECEIVED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 25499861 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  A 76-YEAR-OLD MALE WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY ON (B)(6) 2026. ON (B)(6) 2026, NOVOCURE RECEIVED A REPORT INDICATING THAT THE PATIENT EXPERIENCED SEVERE SCALP PRURITUS. THE PATIENT CONTACTED A PHYSICIAN AND WAS PRESCRIBED AN UNSPECIFIED MEDICATION DESCRIBED AS STRONGER THAN DIPHENHYDRAMINE. THE PATIENT REPORTED THAT THE MEDICATION CAUSED SIGNIFICANT DROWSINESS, PROMPTING A SWITCH TO FEXOFENADINE HYDROCHLORIDE. IT WAS FURTHER REPORTED THAT THE PATIENT HAD USED A TRIPLE ANTIBIOTIC OINTMENT AND TOPICAL DIPHENHYDRAMINE ON THE SCALP. ACCORDING TO THE PATIENT, THE SKIN ON THE ENTIRE BODY WAS VERY PRURITIC, AND THE PATIENT EXPERIENCED EXCESSIVE SWEATING, WHICH WAS ATTRIBUTED TO TEMOZOLOMIDE THERAPY. THE REPORT ADDITIONALLY NOTED ALTERED TASTE SENSATION, SIGNIFICANT FATIGUE, AND STOMACH DISCOMFORT, WHICH THE PATIENT ALSO ATTRIBUTED TO TEMOZOLOMIDE. ON (B)(6) 2026, THE PATIENT REPORTED THAT HE WAS RECOMMENDED BY A HEALTHCARE PROVIDER TO USE ZINC OXIDE CREAM FOR SCALP ITCHINESS. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE PRESCRIBING PHYSICIAN; HOWEVER, NO REPLY WAS RECEIVED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 25442775 ↗