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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOVOCURE LTD. OPTUNE

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NOVOCURE LTD. OPTUNE Back to Search Results
Model Number TFH-9000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Laceration(s) (1946)
Event Date 09/27/2015
Event Type  Injury  
Manufacturer Narrative
Novocure agrees with prescribing physician that the fall was not related to optune therapy.However, the associated laceration was related to optune use.Falls were reported on the ef-14 trial of optune together with temozolomide (tmz) compared to tmz alone in patients with newly diagnosed gbm in both arms of the trial (7% and 2% in optune/tmz and tmz arms respectively).
 
Event Description
Patient with newly diagnosed glioblastoma (gbm) began optune therapy on (b)(6) 2015.On (b)(6) 2015 novocure was informed that on (b)(6) 2015 the patient was hospitalized due to a fall and required sutures for a head wound sustained from mechanical impact with an optune array disk.It was unknown if there was loss of consciousness or seizure activity associated with the fall.The patient was experiencing disease progression at the time of the event.Per prescribing physician, the fall was not related to optune therapy.
 
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Brand Name
OPTUNE
Type of Device
OPTUNE
Manufacturer (Section D)
NOVOCURE LTD.
topaz building, sha'ar
hacarmel 4th floor
haifa, is 31905
IS  31905
Manufacturer (Section G)
NOVOCURE LTD.
topaz building, sha'ar
hacarmel 4th floor
haifa, is 31905
IS   31905
Manufacturer Contact
eilon kirson
topaz building, sha'ar
hacarmel 4th floor
haifa, is 31905
IS   31905
48501204
MDR Report Key5210679
MDR Text Key30725959
Report Number3009453079-2015-00063
Device Sequence Number1
Product Code NZK
UDI-Device Identifier07290107980401
UDI-Public07290107980401
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100034
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial
Report Date 10/09/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberTFH-9000
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Device Age3 YR
Initial Date Manufacturer Received 10/12/2015
Initial Date FDA Received11/09/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/20/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
CO-PHENOTROPE
Patient Outcome(s) Hospitalization;
Patient Age66 YR
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