Optune TFH9100 (REF TFH9100US)Recalls & reported problems

Summary

The FDA's MAUDE database contains 104 adverse event reports that list this exact device (DI 07290107982207), received between Mar 20, 2024 and Jul 29, 2026 — classified as 104 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 104 reports, in the reporter's own words as published by the FDA.

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

  A 65-year-old female with new diagnosed glioblastoma (GBM) started Optune Gio therapy on (b)(6)2023. On (b)(6)2026, the patient informed Novocure that he had been experiencing headaches and occasional sharp head pains since (b)(6)2026, while wearing the arrays. The patient used oxycodone/acetaminophen for the headaches. Multiple attempts were made to contact the prescribing physician; however, no reply was received.

  Patient problems: Headache

  MAUDE report 50070960 ↗
• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem

  A 36-YEAR-OLD MALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY ON (B)(6) 2023. ON (B)(6) 2026, NOVOCURE RECEIVED A MEDICAL RECORD DATED (B)(6) 2026, REPORTING THAT THE PATIENT EXPERIENCED SIGNIFICANT SKIN CHANGES NOTED AFTER REMOVAL OF THE TRANSDUCER ARRAYS. PHYSICAL EXAMINATION REVEALED SEVERAL AREAS OF SKIN BREAKDOWN WITH MINIMAL ERYTHEMA AND SCABBING, MEASURING LESS THAN 5 MM, AND ONE MOST SIGNIFICANT LESION MEASURING APPROXIMATELY 1-2 CM. THE PATIENT WAS ADVISED TO TEMPORARILY DISCONTINUE OPTUNE GIO THERAPY AND TO CLEANSE THE AFFECTED AREAS USING THE LEAST TRAUMATIC METHOD POSSIBLE. DURING A SUBSEQUENT APPOINTMENT ON (B)(6) 2026, IMPROVEMENT OF THE SKIN LESIONS COMPARED TO THE PREVIOUS WEEK WAS NOTED; HOWEVER, THE LESIONS PERSISTED. AT A FOLLOW-UP VISIT ON (B)(6) 2026, THE PATIENT REMAINED ON A THERAPY BREAK, AND THE LESIONS CONTINUED TO BE SCABBED. AN ATTEMPT TO DEBRIDE THE RESIDUAL LESION WITH MINIMAL TRAUMA WAS UNSUCCESSFUL, ALTHOUGH SURROUNDING LESIONS WERE NOTED TO BE NEARLY HEALED. REFERRAL TO A WOUND CLINIC FOR FURTHER MANAGEMENT AND TREATMENT WAS RECOMMENDED. ON (B)(6) 2026, NOVOCURE WAS INFORMED THAT THE PATIENT REMAINED OFF OPTUNE GIO TH

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 24949512 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  A 74-YEAR-OLD FEMALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) BEGAN OPTUNE GIO THERAPY ON (B)(6) 2023. ON (B)(6) 2025, THE PATIENT'S SPOUSE NOTIFIED NOVOCURE THAT THE PATIENT HAD DEVELOPED ERYTHEMA AND SORES ON THE SCALP. THE PATIENT WAS ADVISED BY A HEALTHCARE PROVIDER (HCP) TO DISCONTINUE OPTUNE GIO THERAPY FOR TWO WEEKS. ON JANUARY 02, 2026, NOVOCURE RECEIVED A MEDICAL RECORD DATED ON (B)(6) 2025, DOCUMENTING A SIGNIFICANT WORSENING OF THE PATIENT'S SCALP CONDITION. IT WAS RECOMMENDED THAT THE PATIENT TEMPORARILY DISCONTINUE OPTUNE GIO THERAPY UNTIL SCALP RECOVERY AND CONSULT A DERMATOLOGIST. THE PATIENT WAS PRESCRIBED CLOBETASOL 0.05% SOLUTION, MUPIROCIN 2% OINTMENT, AND GABAPENTIN 100 MG FOR NEUROPATHIC PAIN AND PRURITUS. ON (B)(6) 2025, NOVOCURE WAS INFORMED THAT THE PATIENT'S SCALP CONDITION HAD IMPROVED, AND THE PATIENT WAS ADVISED BY THE HCP TO RESUME OPTUNE GIO THERAPY. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE PRESCRIBING PHYSICIAN; HOWEVER, NO RESPONSE WAS RECEIVED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 24177978 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 51-YEAR-OLD FEMALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) BEGAN OPTUNE GIO THERAPY ON (B)(6) 2023. ON (B)(6) 2025, THE PATIENT INFORMED NOVOCURE THAT ON THE PREVIOUS DAY SHE HAD FALLEN DOWN THE STAIRS WHILE ON OPTUNE GIO THERAPY AND SUSTAINED A SCALP LACERATION REQUIRING SUTURES. THE PATIENT TEMPORARILY DISCONTINUED OPTUNE GIO THERAPY. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE PRESCRIBING PHYSICIAN FOR FURTHER INFORMATION, ALTHOUGH NO REPLY WAS RECEIVED.

  Patient problems: Laceration(s)

  MAUDE report 23739983 ↗
• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 47-YEAR-OLD MALE WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO (B)(6) 2024. ON (B)(6) 2025, THE PATIENT'S CAREGIVER INFORMED NOVOCURE THAT THE PATIENT EXPERIENCED CELLULITIS AND SENT PHOTOS TO THE ONCOLOGIST, WHO ADVISED TEMPORARILY DISCONTINUING OPTUNE GIO THERAPY. THE CAREGIVER PLANNED TO CONTACT THE PRIMARY CARE PHYSICIAN TO REQUEST A STRONGER UNSPECIFIED ANTIBIOTIC PRESCRIPTION. ON (B)(6) 2025, THE CAREGIVER CONFIRMED THAT CELLULITIS PERSISTED AND ANOTHER 10-DAY COURSE OF ANTIBIOTICS WAS INITIATED. BY ON (B)(6) 2025, A THIRD ROUND OF ANTIBIOTICS WAS REQUIRED, WITH APPROXIMATELY ONE WEEK OF TREATMENT REMAINING, ALTHOUGH THE CONDITION APPEARED TO BE IMPROVING. ON (B)(6) 2025, THE CAREGIVER STATED THAT THE ANTIBIOTIC COURSE HAD BEEN COMPLETED, BUT CELLULITIS HAD RECURRED. ON (B)(6) 2025, THE CAREGIVER CONFIRMED THAT TREATMENT HAD NOT RESUMED, AS THE DERMATOLOGIST PRESCRIBED THREE ADDITIONAL UNSPECIFIED MEDICATIONS. THE PATIENT WOULD NOT RESUME OPTUNE GIO UNTIL THE SCALP WAS COMPLETELY HEALED. ON NOVEMBER 03, 2025, NOVOCURE RECEIVED A MEDICAL RECORD DATED ON (B)(6) 2025, WHICH CONFIRMED PREVIOUS FINDINGS OF SCALP IRRITATION AND WOUNDS REQUIRING ANTIBIOTICS, WITH OPTU

  Patient problems: Cellulitis

  MAUDE report 23618067 ↗
• InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 61-YEAR-OLD FEMALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) INITIATED OPTUNE GIO THERAPY ON (B)(6) 2024. ON (B)(6) 2025, NOVOCURE RECEIVED A MEDICAL RECORD DATED (B)(6) 2025, INDICATING THAT THE PATIENT DEVELOPED A RASH ASSOCIATED WITH OPTUNE GIO THERAPY. THE RASH WAS UNRESPONSIVE TO TOPICAL CLOBETASOL AND DIPHENHYDRAMINE CREAM. IT RESOLVED FOLLOWING THE ADMINISTRATION OF DEXAMETHASONE, WHICH HAD ORIGINALLY BEEN PRESCRIBED ON (B)(6) 2024, FOR GAIT DISTURBANCE AND NAUSEA UNRELATED TO OPTUNE GIO THERAPY. DUE TO THE PERSISTENCE OF THE RASH, THE PATIENT WAS ADVISED TO INITIATE LOW-DOSE PREDNISONE THERAPY. PREDNISONE 10 MG WAS SUBSEQUENTLY PRESCRIBED. ON (B)(6) 2025, THE HEALTHCARE PROVIDER CONFIRMED THAT THE PATIENT HAD BEEN PRESCRIBED 5 MG OF PREDNISONE DAILY FOR THE MANAGEMENT OF SKIN IRRITATION ASSOCIATED WITH OPTUNE GIO THERAPY. THE PATIENT WAS ALSO RECEIVING BEVACIZUMAB AT THAT TIME AND CONTINUED OPTUNE GIO THERAPY.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 23485326 ↗
• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 77-YEAR-OLD FEMALE WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY ON (B)(6) 2021. ON (B)(6) 2025, THE PATIENT'S SPOUSE INFORMED NOVOCURE THAT THE PATIENT EXPERIENCED A FALL ON (B)(6) 2025. THE SPOUSE REPORTED THAT HE WAS UNSURE OF THE EXACT CIRCUMSTANCES, BUT THE PATIENT WAS WALKING DOWN THE HALLWAY WHEN SHE COLLAPSED. THE PATIENT WAS REPORTEDLY COHERENT AND RESPONSIVE. SUBSEQUENTLY, THE PATIENT WAS TAKEN TO THE HOSPITAL AND ADMITTED TO THE INTENSIVE CARE UNIT, WHERE A (CT) COMPUTED TOMOGRAPHY SCAN REVEALED TWO INTRACRANIAL HEMORRHAGES AND A SUSPECTED SEIZURE. IN ADDITION, THE INCIDENT RESULTED IN A MINOR LACERATION TO THE OCCIPITAL REGION OF THE SCALP, WHICH REQUIRED CLOSURE WITH FOUR STAPLES. THE PATIENT WAS ON ANTI-SEIZURE MEDICATION AND ADJUSTMENTS TO HER REGIMEN WERE MADE. AT THE TIME OF THE FALL, THE PATIENT WAS WEARING THE OPTUNE GIO DEVICE. AN IMAGE PROVIDED SHOWS THE OCCIPITAL SCALP AREA WITH FOUR STAPLES IN PLACE WITH THE TRANSDUCER ARRAYS PLACED TO AVOID THE AFFECTED AREA. NO SIGNS OF ACTIVE BLEEDING, DRAINAGE, OR ERYTHEMA WERE OBSERVED. ATTEMPTS WERE MADE TO CONTACT THE HEALTHCARE PROVIDER (HCP) FOR ADDITIONAL CLINICAL DETAILS REGARDING THE EVENT;

  Patient problems: Laceration(s)

  MAUDE report 23355007 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 77-YEAR-OLD FEMALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) BEGAN OPTUNE GIO THERAPY ON (B)(6) 2022. ON (B)(6) 2025, THE PATIENT INFORMED NOVOCURE THAT THE PRESCRIBING PHYSICIAN HAD REFERRED HER TO A WOUND CARE SPECIALIST DUE TO SKIN CONCERNS ON THE SCALP THAT OCCURRED ON (B)(6) 2025. THE PATIENT NOTED THE SKIN APPEARED MORE BRUISED WITH OPEN SORES, PEELING SKIN, AND RAISED BUMPS ON THE RIGHT SIDE OF THE HEAD. OPTUNE GIO THERAPY WAS TEMPORARILY DISCONTINUED. THE IMAGES PROVIDED SHOWED A RAISED, ERYTHEMATOUS LESION WITH A CENTRAL PALE AREA ACCOMPANIED BY A SECOND SMALLER LESION. ADDITIONAL FINDINGS INCLUDED YELLOWISH CRUSTING, SMALL EROSIONS IN THE VICINITY OF THE LESIONS, AND MILD TO MODERATE ERYTHEMA THROUGHOUT THE SCALP. ATTEMPTS WERE MADE TO CONTACT THE PRESCRIBING PHYSICIAN FOR ADDITIONAL INFORMATION; HOWEVER, NO RESPONSE WAS RECEIVED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 23298120 ↗
• InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 77-YEAR-OLD FEMALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY ON (B)(6) 2021. ON (B)(6) 2025, NOVOCURE WAS NOTIFIED BY THE PATIENT'S SPOUSE THAT THE PATIENT WAS UNABLE TO TOLERATE THE NEW TRANSDUCER ARRAYS. FOLLOWING A SINGLE APPLICATION, THE PATIENT DEVELOPED A BURNING SENSATION WITHIN 2-3 HOURS. PRE-EXISTING BLISTERS BECAME INFECTED, NECESSITATING THE USE OF UNSPECIFIED ORAL ANTIBIOTICS AND RESULTING IN A ONE-MONTH INTERRUPTION IN OPTUNE GIO THERAPY. THE SPOUSE EXPRESSED CONCERN THAT THE PATIENT MAY HAVE HAD AN ALLERGIC REACTION TO THE FLEXIBLE POLYMER IN THE NEW ARRAYS. IT WAS ALSO NOTED THAT THE PATIENT HAD CONSULTED A DERMATOLOGIST DUE TO DERMAL ATROPHY FROM PRIOR RADIATION AND WAS USING A STEROID CREAM AND TOPICAL ANTIBIOTIC AS NEEDED. ON AUGUST 25, 2025, MEDICAL RECORDS WERE RECEIVED FROM THE PRESCRIBING PHYSICIAN. DOCUMENTATION DATED (B)(6) 2025, INDICATED THAT THE PATIENT EXPERIENCED INCREASED SCALP IRRITATION AND WORSENING SKIN LESIONS FOLLOWING THE TRANSITION TO THE NEW ARRAYS. AS A RESULT, THE PHYSICIAN RECOMMENDED TEMPORARILY DISCONTINUING OPTUNE GIO THERAPY TO ALLOW FOR SKIN RECOVERY.

  Patient problems: Skin Infection

  MAUDE report 23060687 ↗
• InjurySep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 34-YEAR-OLD MALE PATIENT WITH RECURRENT ANAPLASTIC ASTROCYTOMA BEGAN OPTUNE GIO THERAPY ON (B)(6), 2024. ON (B)(6), 2024, THE PATIENT REPORTED TO NOVOCURE THAT HE DEVELOPED AN ULCER AT THE SURGICAL RESECTION SITE SCAR. THE PATIENT CONSULTED A HEALTHCARE PROVIDER (HCP), WHO ADVISED A TEMPORARY DISCONTINUATION OF OPTUNE GIO THERAPY. ON (B)(6), 2024, THE PATIENT INDICATED THAT THERAPY WOULD REMAIN PAUSED FOR A FEW MORE WEEKS. NO MEDICAL INTERVENTION WAS REPORTED AT THAT TIME. ON (B)(6), 2025, NOVOCURE RECEIVED A MEDICAL RECORD DOCUMENTING A NEURO-ONCOLOGY CLINIC VISIT ON (B)(6), 2024. DURING THIS VISIT, THE PATIENT WAS NOTED TO HAVE AN AREA OF INCOMPLETE HEALING AT THE INCISION SITE, WITH INTERMITTENT SEROUS DRAINAGE. TREATMENT INCLUDED CEPHALEXIN 500 MG ADMINISTERED TWICE DAILY. ON (B)(6), 2024, IT WAS REPORTED THAT THE PATIENT UNDERWENT A WOUND WASHOUT PROCEDURE FOR AN INFECTED SURGICAL INCISION ON (B)(6), 2024, FOLLOWED BY A CRANIOPLASTY ON (B)(6), 2024. ON (B)(6), 2025, THE PATIENT'S SPOUSE REPORTED THAT THE PATIENT EXPERIENCED SKIN IRRITATION. THE HCP AGAIN RECOMMENDED A TEMPORARY DISCONTINUATION OF OPTUNE GIO THERAPY AND PRESCRIBED AN UNSPECIFIED ORAL MEDICATION. MULTIPLE ATTE

  Patient problems: Post Operative Wound Infection; Skin Inflammation/ Irritation

  MAUDE report 22949895 ↗
• InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 71-YEAR-OLD MALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY ON (B)(6) 2023. ON (B)(6) 2025, NOVOCURE RECEIVED A MEDICAL RECORD, INDICATING THAT THE PATIENT DEVELOPED A HUNCHED POSTURE, ATTRIBUTED TO PROLONGED USE OF OPTUNE GIO THERAPY EXCEEDING 18 HOURS PER DAY. IT WAS ALSO NOTED THAT THE PATIENT HAD CHRONIC RIGHT SIDED WEAKNESS. THE PATIENT WAS REFERRED TO PHYSICAL THERAPY AND CONTINUED THE USE OF OPTUNE GIO THERAPY. SEVERAL ATTEMPTS WERE MADE TO CONTACT THE PRESCRIBING PHYSICIAN FOR ADDITIONAL INFORMATION, ALTHOUGH NO REPLY WAS RECEIVED.

  Patient problems: Spinal deformity

  MAUDE report 22882232 ↗
• InjuryAug 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 35-YEAR-OLD MALE PATIENT WITH DIFFUSE MIDLINE GLIOMA BEGAN OPTUNE GIO THERAPY ON (B)(6) 2024. ON (B)(6) 2025, NOVOCURE WAS NOTIFIED THAT THE PATIENT TEMPORARILY DISCONTINUED OPTUNE GIO THERAPY DUE TO A SHUNT INFECTION THAT NECESSITATED SURGICAL REMOVAL. THE CAREGIVER BELIEVED THAT THE INFECTION WAS UNRELATED TO DEVICE USE. DURING AN IN-HOME VISIT ON (B)(6) 2025, IT WAS NOTED THAT THE PATIENT HAD A LARGE VENTRICULOPERITONEAL SHUNT, WHICH WAS PLACED ON (B)(6) 2023, ON THE TOP-LEFT SIDE OF THE HEAD, AND THE ARRAYS WERE PLACED TO AVOID THE AREA. ON (B)(6) 2025, FURTHER INFORMATION WAS PROVIDED INDICATING THAT THE PATIENT STILL HAD SUTURES IN PLACE ON THE SCALP FOLLOWING THE SURGERY. AS A RESULT, OPTUNE GIO THERAPY COULD NOT BE RESUMED UNTIL THE SCALP FULLY HEALED. THE PRESCRIBING PHYSICIAN WAS CONTACTED FOR FURTHER DETAILS, ALTHOUGH NO REPLY WAS RECEIVED.

  Patient problems: Medical device site infection

  MAUDE report 22826305 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 64-YEAR-OLD MALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY ON (B)(6) 2024. ON (B)(6) 2025, THE PATIENT REPORTED TO NOVOCURE THAT AFTER REMOVING THE ARRAYS, FOLLOWING A FEW DAYS OF OPTUNE GIO THERAPY, HE HAD DEVELOPED A SKIN REACTION CHARACTERIZED BY BLISTERING, BLEEDING, PRURITUS, AND A BURNING SENSATION. AS A RESULT, OPTUNE GIO THERAPY WAS TEMPORARILY DISCONTINUED. THE PATIENT WAS EVALUATED BY A DERMATOLOGIST, WHO PRESCRIBED UNSPECIFIED ALLERGY MEDICATIONS ALONG WITH A TOPICAL CREAM. THE PRESCRIBING PHYSICIAN WAS CONTACTED FOR FURTHER DETAILS, ALTHOUGH NO REPLY WAS RECEIVED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 22661662 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 71-YEAR-OLD FEMALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY ON (B)(6) 2024. ON (B)(6) 2025, THE PATIENT INFORMED NOVOCURE THAT, APPROXIMATELY TWO WEEKS PRIOR, SHE PLACED THE DEVICE ON THE BATHROOM SINK AND THE DEVICE SUBSEQUENTLY FELL ONTO HER FOOT, RESULTING IN FRACTURES TO TWO BONES. THE PATIENT BELIEVED THAT THE WEIGHT OF THE DEVICE WAS THE CAUSE OF THE INJURY. THE PATIENT WENT TO THE EMERGENCY ROOM (ER) AND WAS GIVEN A FOOT BRACE. THE PATIENT REMAINED ON OPTUNE GIO THERAPY. THE PATIENT'S PRESCRIBING PHYSICIAN WAS CONTACTED FOR ADDITIONAL INFORMATION, ALTHOUGH NO REPLY WAS RECEIVED.

  Patient problems: Bone Fracture(s)

  MAUDE report 22554177 ↗
• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 46-YEAR-OLD MALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY ON (B)(6) 2024. ON (B)(6) 2025, THE PATIENT REPORTED TO NOVOCURE THAT HE HAD DEVELOPED A SIGNIFICANT REACTION TO ONE OF HIS DAILY CHEMOTHERAPY MEDICATIONS, PRESENTING AS PUSTULES ACROSS THE ENTIRE SCALP. A MEDICAL RECORD RECEIVED BY NOVOCURE ON JUNE 13, 2025, REFERENCED A NEURO-ONCOLOGY APPOINTMENT ON (B)(6) 2025, DURING WHICH THE PATIENT WAS NOTED TO HAVE SCALP IRRITATION CHARACTERIZED BY ERYTHEMA AND A FEW CRUSTED SORES DUE TO OPTUNE GIO THERAPY AND REPORTEDLY WAS USING AN UNSPECIFIED TOPICAL STEROID CREAM. AT A FOLLOW UP APPOINTMENT ON (B)(6) 2025, THE PATIENT WAS DIAGNOSED WITH FOLLICULITIS AND PRESCRIBED DOXYCYCLINE 100MG ORALLY ONCE DAILY. IMAGES PROVIDED SHOWED DIFFUSE, SCATTERED PUSTULES ACROSS THE SCALP WITH MILD TO MODERATE ERYTHEMA. ONE IMAGE REVEALED A SMALL REGION OF CRUSTED EXUDATE WITH MODERATE ERYTHEMA. OPTUNE GIO THERAPY WAS TEMPORARILY DISCONTINUED. ATTEMPTS TO CONTACT THE PRESCRIBING PHYSICIAN FOR FURTHER DETAILS WERE MADE, BUT NO RESPONSE WAS RECEIVED.

  Patient problems: Skin Infection

  MAUDE report 22409648 ↗
• InjuryJun 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 33-YEAR-OLD FEMALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) BEGAN OPTUNE GIO THERAPY ON (B)(6) 2022. ON (B)(6) 2025, NOVOCURE WAS NOTIFIED THAT THE PATIENT HAD AN APPOINTMENT WITH THEIR HEALTHCARE PROVIDER (HCP) ON THAT DATE DUE TO UNSPECIFIED FINDINGS ON A PRIOR MRI SCAN AND TO PLAN FOR SURGERY SCHEDULED ON (B)(6) 2025. AS A RESULT, OPTUNE GIO THERAPY WAS TEMPORARILY DISCONTINUED. ON (B)(6) 2025, THE PATIENT'S CAREGIVER REPORTED THAT THE PATIENT VISITED THE HCP FOR SUTURE REMOVAL. ON (B)(6) 2025, NOVOCURE WAS INFORMED THAT THE PATIENT HAD RESUMED OPTUNE GIO THERAPY ON (B)(6) 2025. ADDITIONALLY, THE PATIENT UNDERWENT AN EVALUATION AT THE HOSPITAL DUE TO DRAINAGE OBSERVED NEAR THE SURGICAL RESECTION SITE. NO FURTHER CLINICAL DETAILS WERE PROVIDED. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE PRESCRIBING PHYSICIAN; HOWEVER, NO RESPONSE WAS RECEIVED.

  Patient problems: Impaired Healing

  MAUDE report 22138995 ↗
• InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 65-YEAR-OLD FEMALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY ON (B)(6) 2024. ON (B)(6) 2025, A MEDICAL RECORD DATED ON (B)(6) 2024, WAS RECEIVED BY NOVOCURE, DOCUMENTING THAT THE PATIENT DEVELOPED CONTACT DERMATITIS ASSOCIATED WITH OPTUNE GIO THERAPY, DESCRIBED AS BURNING AND PERSISTENT PRURITUS. MANAGEMENT INCLUDED ORAL HYDROXYZINE 12.5 MG NIGHTLY, CETIRIZINE 20 MG TWICE DAILY, CLOBETASOL FOAM, MUPIROCIN 2% OINTMENT, AND TRIAMCINOLONE 0.1% OINTMENT. AT A FOLLOW-UP ON (B)(6) 2025, THE PATIENT REPORTED IMPROVEMENT WITH CLOBETASOL FOAM, AND CLINICAL EXAMINATION SHOWED REDUCED REDNESS AND RESOLUTION OF ERYTHEMATOUS PAPULES ON THE SCALP. MUPIROCIN WAS DISCONTINUED DUE TO THE ABSENCE OF OPEN LESIONS; OTHER TREATMENTS WERE CONTINUED. HOWEVER, DURING A SUBSEQUENT VISIT ON (B)(6) 2025, THE PATIENT REPORTED ONGOING SYMPTOMS, INCLUDING BURNING AND ITCHING OF THE SCALP. THE PHYSICIAN'S EXAMINATION REVEALED ERYTHEMATOUS, SCALY, AND CRUSTED PLAQUES. THE PHYSICIAN ADVISED RESTARTING MUPIROCIN 2% OINTMENT TWICE DAILY FOR OPEN LESIONS, CONTINUING CLOBETASOL (FOAM OR OINTMENT), INITIATING DAILY HYPOCHLOROUS ACID SPRAY, AND MAINTAINING USE OF CETIRIZINE AND HYDROXY

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 22076754 ↗
• InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 68-YEAR-OLD FEMALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT'S DAUGHTER REPORTED TO NOVOCURE THAT SHE OBSERVED AN OPEN SORE NEAR THE PATIENT'S PRIOR SURGICAL RESECTION SITE (LAST SURGICAL RESECTION (B)(6) 2024) UPON REMOVAL OF THE TRANSDUCER ARRAYS. AN IMAGE PROVIDED REVEALED A WOUND DEHISCENCE AT THE SITE OF THE SURGICAL RESECTION SCAR, WITH EXPOSED SURGICAL HARDWARE AND ASSOCIATED MILD TO MODERATE ERYTHEMA. OPTUNE GIO THERAPY WAS TEMPORARILY DISCONTINUED. ATTEMPTS TO CONTACT THE PRESCRIBING PHYSICIAN FOR FURTHER DETAILS WERE MADE, BUT NO RESPONSE WAS RECEIVED.

  Patient problems: Wound Dehiscence

  MAUDE report 22076638 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 73-YEAR-OLD FEMALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY ON (B)(6) 2023. ON (B)(6) 2025, NOVOCURE WAS INFORMED BY THE PATIENT'S NEUROLOGIST THAT SHE HAD BEEN EXPERIENCING PERSISTENT, INTERMITTENT PRURITUS AND ERYTHEMA OF THE SCALP, OCCURRING DAILY AND ATTRIBUTED TO OPTUNE GIO THERAPY. THE CURRENT TREATMENT REGIMEN INCLUDED GABAPENTIN 200 MG TWICE DAILY, DIPHENHYDRAMINE 12.5 MG AS NEEDED, AND HYDROXYZINE 5-10 MG AS NEEDED IF DIPHENHYDRAMINE WAS INEFFECTIVE. ADDITIONALLY, THE PATIENT APPLIED CLOBETASOL CREAM TO AFFECTED AREAS WHEN ERYTHEMATOUS AND TEMPORARILY DISCONTINUED THERAPY UNTIL SYMPTOMS RESOLVED. ON (B)(6) 2025, THE HEALTHCARE PROVIDER (HCP) REPORTED THAT THE PATIENT WAS ADVISED TO USE WITCH HAZEL AS AN ALTERNATIVE TO STANDARD ALCOHOL-BASED SKIN PREPARATION. A WATER-BASED SKIN BARRIER COULD BE APPLIED FOLLOWING WITCH HAZEL USE. THE HCP ALSO RECOMMENDED THE USE OF TOPICAL ANTIHISTAMINES AND CORTICOSTEROIDS BETWEEN ARRAY CHANGES TO PREVENT OR MANAGE HYPERSENSITIVITY REACTIONS AND PRURITUS. THE PRESCRIBING PHYSICIAN ADVISED INCREASING THE GABAPENTIN DOSAGE TO 200 MG THREE TIMES DAILY TO ASSESS IMPROVED EFFICACY. THE HCP DID NOT PROVIDE A CA

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 22025466 ↗
• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 58-YEAR-OLD MALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY ON (B)(6) 2025. ON APRIL 08, 2025, NOVOCURE WAS INFORMED THAT, DURING A TRANSDUCER ARRAY CHANGE ON (B)(6) 2025, PIMPLE-LIKE SORES APPROXIMATELY ONE CENTIMETER IN SIZE WERE OBSERVED SPORADICALLY ON THE PATIENT'S LEFT EAR AND ON THE POSTERIOR LEFT SIDE OF THE SCALP. AS A RESULT, OPTUNE GIO THERAPY WAS TEMPORARILY DISCONTINUED. ON (B)(6) 2025, THE PATIENT'S SPOUSE REPORTED THAT THE PATIENT HAD BEEN EVALUATED BY THE HEALTHCARE PROVIDER (HCP) AND DIAGNOSED WITH FOLLICULITIS. THE HCP PRESCRIBED DOXYCYCLINE 100 MG, TO BE TAKEN TWICE DAILY FOR SEVEN DAYS. THE PATIENT RESUMED OPTUNE GIO THERAPY THE SAME DAY. HOWEVER, ON (B)(6) 2025, IT WAS REPORTED THAT THE PRESCRIBING PHYSICIAN EVALUATED THE PATIENT AND ADVISED DISCONTINUING THERAPY AGAIN, PENDING A FOLLOW-UP VISIT SCHEDULED FOR ON (B)(6) 2025. ATTEMPTS TO CONTACT THE PRESCRIBING PHYSICIAN WERE MADE, ALTHOUGH NO REPLY WAS RECEIVED.

  Patient problems: Skin Infection

  MAUDE report 21947962 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 68-YEAR-OLD MALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY ON (B)(6) 2024. DURING THE REVIEW OF THE PATIENT'S MEDICAL RECORDS RECEIVED BY NOVOCURE ON JANUARY 29, 2025, IT WAS NOTED THAT THE PATIENT HAD EXPERIENCED SIGNIFICANT SCALP IRRITATION, MINIMAL ITCHING, AND A MILD RASH RELATED TO OPTUNE GIO THERAPY. ADDITIONAL MEDICAL RECORDS RECEIVED ON APRIL 01, 2025, DOCUMENTED A NEURO-ONCOLOGY CLINIC VISIT ON (B)(6) 2025, DURING WHICH THE PATIENT REPORTED SKIN IRRITATION AND SCALP PRURITUS ATTRIBUTED TO ONGOING OPTUNE GIO THERAPY. THE PATIENT MANAGED THE DISCOMFORT BY TAPPING HIS HEAD TO ALLEVIATE AND PREVENT THE ITCHING. TO ADDRESS THE PRURITUS, THE PATIENT WAS PRESCRIBED GABAPENTIN 300 MG EACH MORNING FOR THREE DAYS. IF NO IMPROVEMENT WAS OBSERVED, HYDROXYZINE HCL 10 MG, THREE TIMES DAILY AS NEEDED, WAS RECOMMENDED AS AN ALTERNATIVE. THE PATIENT REMAINED ON OPTUNE GIO THERAPY. ATTEMPTS TO CONTACT THE PRESCRIBING PHYSICIAN WERE MADE, ALTHOUGH NO REPLY WAS RECEIVED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 21906637 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 50-YEAR-OLD MALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) BEGAN OPTUNE GIO THERAPY ON (B)(6) 2024. ON MARCH 26, 2025, NOVOCURE RECEIVED A MEDICAL RECORD DATED (B)(6) 2025, DOCUMENTING THAT THE PATIENT EXPERIENCED CONTACT DERMATITIS RELATED TO OPTUNE GIO THERAPY AND WAS TREATED WITH A COURSE OF ANTIBIOTICS DUE TO POTENTIAL CELLULITIS. THE PATIENT WAS ADVISED TO CONTINUE WITH OPTUNE GIO THERAPY ALONG WITH A TOPICAL STEROID TO REDUCE SKIN TOXICITY. ADDITIONAL RECOMMENDATIONS INCLUDED THE APPLICATION OF BABY MINERAL OIL TO FACILITATE ARRAY REMOVAL AND TO APPLY SILVER SULFADIAZINE CREAM TO NONHEALING AREAS. ATTEMPTS TO CONTACT THE PRESCRIBING PHYSICIAN WERE MADE, ALTHOUGH NO REPLY WAS RECEIVED.

  Patient problems: Cellulitis; Skin Inflammation/ Irritation

  MAUDE report 21855248 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 48-YEAR-OLD MALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY ON (B)(6) 2019. DURING REVIEW OF MEDICAL RECORDS RECEIVED BY NOVOCURE ON (B)(6) 2025, IT WAS NOTED THAT DURING AN ONCOLOGY APPOINTMENT ON (B)(6) 2025, THE PATIENT EXPERIENCED A SKIN REACTION DESCRIBED AS REDNESS AND PUSTULES, WITHOUT ANY VISIBLE BREAKDOWN OR ULCERATION WHILE ON OPTUNE GIO THERAPY. THE PATIENT WAS REPORTED TO BE TAKING UNSPECIFIED ORAL ANTIHISTAMINES. ON (B)(6) 2025, NOVOCURE WAS NOTIFIED THAT THE PATIENT DEVELOPED TWO AREAS OF VERY RED, RAW SPOTS NEAR THE SURGICAL RESECTION SCAR, WHICH WERE BEGINNING TO SCAB OVER. AN IMAGE PROVIDED DEPICTED TWO WOUNDS ON THE SURGICAL RESECTION SCAR, WITH MILD ERYTHEMA AND YELLOW TINGED EXUDATE. AS A RESULT, OPTUNE GIO THERAPY WAS TEMPORARILY DISCONTINUED. ATTEMPTS TO CONTACT THE PRESCRIBING PHYSICIAN FOR FURTHER DETAILS WERE MADE, BUT NO RESPONSE WAS RECEIVED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 21675423 ↗
• InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 58-YEAR-OLD FEMALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO ON (B)(6) 2024. ON (B)(6) 2025, THE PATIENT REPORTED TO NOVOCURE THAT ON (B)(6) 2025; WHILE WALKING FAST PAST A DOOR, THE ARRAY CORDS BECAME ENTANGLED ON A DOORKNOB, CAUSING HER TO BE PULLED BACKWARD. THE PATIENT SUBSEQUENTLY EXPERIENCED NECK PAIN, DESCRIBED AS A WHIPLASH-LIKE SENSATION. FOLLOWING THE INCIDENT, SHE SOUGHT CHIROPRACTIC CARE, DURING WHICH IT WAS NOTED THAT TWO OF HER RIBS HAD BECOME DISPLACED. ATTEMPTS TO CONTACT THE PRESCRIBING PHYSICIAN FOR FURTHER DETAILS WERE MADE, BUT NO RESPONSE WAS RECEIVED.

  Patient problems: Joint Dislocation; Neck Pain

  MAUDE report 21408234 ↗
• InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 52-YEAR-OLD FEMALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY ON (B)(6) 2022. DURING REVIEW OF THE PATIENT'S MEDICAL RECORDS, RECEIVED ON (B)(6) 2025, IT WAS NOTED THAT THE PATIENT DEVELOPED CELLULITIS ON THE SCALP IN (B)(6) 2024. THE PATIENT WAS TREATED WITH ORAL CEPHALEXIN AND INSTRUCTED TO APPLY SILVER SULFADIAZINE CREAM TO THE AFFECTED AREAS. THE PATIENT REPORTED IMPROVEMENT AFTER CHANGING THE TRANSDUCER ARRAYS EVERY 36 HOURS AND ALTERING HER SCALP CLEANING METHOD BEFORE SHAVING. THE EVENT WAS DOCUMENTED DURING FOLLOW UP APPOINTMENTS WITH THE PATIENT'S PHYSICIAN ON (B)(6) 2024, AND (B)(6) 2025. ATTEMPTS TO CONTACT THE PRESCRIBING PHYSICIAN FOR FURTHER DETAILS WERE MADE, BUT NO RESPONSE WAS RECEIVED.

  Patient problems: Cellulitis

  MAUDE report 21353162 ↗