MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-05-21 for OPTUNE TFH-91000 N/A manufactured by Novocure, Ltd..
[145683285]
Novocure's medical opinion is that a contribution of the array placement to the event cannot be ruled out. Contributing factors for wound dehiscence and wound infection in this patient also include concomitant dexamethasone (impaired wound healing and increased risk of infection are listed as side effects. Source: dexamethasone prescribing information), prior radiation, chemotherapy, and prior surgery affecting skin integrity. Wound infection is an expected event with device use and was reported as an adverse event in the (b)(6) trial of optune together with temozolomide (tmz) compared to tmz alone in patients with newly diagnosed gbm in both arms of the trial (<1% and <1% in optune/tmz and tmz arms respectively). Wound dehiscence was reported in the optune/tmz arm of the trial (<1%) only.
Patient Sequence No: 1, Text Type: N, H10
[145683286]
A (b)(6) female patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2019. On april 29, 2019, spouse reported that the patient had been hospitalized on (b)(6) 2019. When removing the transducer arrays from the scalp on (b)(6) 2019, it was discovered that an abscess had formed on the craniotomy resection scar site (last resection (b)(6) 2018). On (b)(6) 2019, patient underwent wound revision surgery and removal of the bone flap. Per prescribing physician, cause of the event was due to late surgery infection and high dose steroid medication (dexamethasone, 24 mg daily) and unrelated to optune therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009453079-2019-00116 |
| MDR Report Key | 8629223 |
| Report Source | CONSUMER |
| Date Received | 2019-05-21 |
| Date of Report | 2019-05-21 |
| Date of Event | 2019-04-26 |
| Date Mfgr Received | 2019-04-29 |
| Device Manufacturer Date | 2019-01-09 |
| Date Added to Maude | 2019-05-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. SHARON PEREZ |
| Manufacturer Street | 195 COMMERCE WAY |
| Manufacturer City | PORTSMOUTH NH 03801 |
| Manufacturer Country | US |
| Manufacturer Postal | 03801 |
| Manufacturer Phone | 6033191907 |
| Manufacturer G1 | NOVOCURE, LTD. |
| Manufacturer Street | 195 COMMERCE WAY |
| Manufacturer City | PORTSMOUTH NH 03801 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 03801 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTUNE |
| Generic Name | OPTUNE |
| Product Code | NZK |
| Date Received | 2019-05-21 |
| Model Number | TFH-91000 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOVOCURE, LTD. |
| Manufacturer Address | 195 COMMERCE WAY PORTSMOUTH NH 03801 US 03801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-05-21 |