OptuneRecalls & reported problems across all models
Novocure GmbH · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 148
- Deaths reported
- 0
- Injuries reported
- 148
- Recalls
- 0
We found 3 models of Optune by Novocure GmbH in the FDA's device registry (GUDID). Together they are named in 148 adverse event reports in the FDA's MAUDE database, received between Nov 9, 2021 and Jul 29, 2026 — classified as 148 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Optune problems
Device problems
- Adverse Event Without Identified Device or Use Problem147
- Use of Device Problem1
Patient problems
- Skin Inflammation/ Irritation27
- Wound Dehiscence26
- Laceration(s)20
- Post Operative Wound Infection20
- Ulcer16
- Skin Infection11
- Fall8
- Headache7
Optune models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Optune TFH9100Stimulator, Low Electric Field, Tumor Treatment104 reports
- Optune TFH9100Stimulator, Low Electric Field, Tumor Treatment38 reports
- Optune TFH9100Stimulator, Low Electric Field, Tumor Treatment6 reports
Recent Optune adverse event reports
The 15 most recent reports across all models, 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 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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