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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CLINICAL INNOVATIONS, LLC GOLDTRACE FETAL SPIRAL ELECTRODE

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CLINICAL INNOVATIONS, LLC GOLDTRACE FETAL SPIRAL ELECTRODE Back to Search Results
Model Number CNS000004
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Type  malfunction  
Manufacturer Narrative
We are investigating the complaint and gathering more information to determine what has caused the tip to brake. We are trying to locate the device to do an investigation.
 
Event Description
During the removal of the fse, a piece of the spiral needle of this electrode remained stuck under the skin of the baby's head. The piece remained there for 2 months. The broken part had to been surgically removed.
 
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Brand NameGOLDTRACE
Type of DeviceFETAL SPIRAL ELECTRODE
Manufacturer (Section D)
CLINICAL INNOVATIONS, LLC
747 w 4170 s
murray UT 84123
Manufacturer (Section G)
CLINICAL INNOVATIONS, LLC
747 w 4170 s
murray UT 84123
Manufacturer Contact
santosh bhagat
747 w 4170 s
murray, UT 84123
8012688200
MDR Report Key7125185
MDR Text Key96038300
Report Number1722684-2017-00016
Device Sequence Number1
Product Code HGP
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K030691
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Remedial Action Patient Monitoring
Type of Report Initial
Report Date 12/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCNS000004
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/15/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/18/2017 Patient Sequence Number: 1
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