MAUDE Adverse Event Report: FHC, INC. FHC STERILE DZAP ARRAY INSERTION ELECTRODE; DEPTH ELECTRODE

Model Number FC2001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Intracranial Hemorrhage (1891)

Event Date 01/16/2020

Event Type  Injury  

Event Description

An event at hospital in (b)(6) involving fhc product model fc2001 on (b)(6) 2020.Event was described as follows: "at the time of intraoperative stimulation, there was abnormality in the patient's condition.The product was extracted immediately and it was discontinued.After that, ct scan was performed.Intracerebral hemorrhage occurred during intraoperative stimulation.The patient was in the condition of upper limb hemiplegia." report notes that the patient is alive-with injury and this was a factor of surgical procedure.The report also notes that the event had no relation with the product.Product was discarded by user and was not returned to the manufacturer for evaluation.

• Brand Name: FHC STERILE DZAP ARRAY INSERTION ELECTRODE
• Type of Device: DEPTH ELECTRODE
• Manufacturer (Section D): FHC, INC.; 1201 main street; bowdoin, me
• Manufacturer (Section G): FHC, INC.; 1201 main street; bowdoin, me
• Manufacturer Contact: kelly moeykens ; 1201 main street; bowdoin, me ; 6665651219
• MDR Report Key: 9699816
• MDR Text Key: 191198722
• Report Number: 3002250546-2020-00001
• Device Sequence Number: 1
• Product Code: GZL
• UDI-Device Identifier: 10873263007492
• UDI-Public: 10873263007492
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/12/2020

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: Health Professional
• Device Model Number: FC2001
• Device Catalogue Number: FC2001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/20/2020
• Initial Date FDA Received: 02/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other