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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FHC, INC. MICROELECTRODE RECORDING PRODUCT; ELECTRODE, DEPTH

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FHC, INC. MICROELECTRODE RECORDING PRODUCT; ELECTRODE, DEPTH Back to Search Results
Device Problem Defective Component (2292)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
A medtronic employee reported that a customer informed them that they had a bad electrode on an fhc microelectrode recording product.An e-mail was sent to fch at quality@fh-co.Com on 4/18/2013 to inform them of this reported complaint.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
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Brand Name
MICROELECTRODE RECORDING PRODUCT
Type of Device
ELECTRODE, DEPTH
Manufacturer (Section D)
FHC, INC.
MDR Report Key17533377
MDR Text Key321198101
Report NumberMW5140281
Device Sequence Number1
Product Code GZL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 10/07/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/12/2023
Patient Sequence Number1
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