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U.S. Department of Health and Human Services

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

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CLINICAL INNOVATIONS, LLC GOLDTRACE FETAL SPIRAL ELECTRODE FETAL SCALP ELECTRODE Back to Search Results
Model Number CNS000004
Device Problem Break (1069)
Patient Problem Pain (1994)
Event Date 07/21/2017
Event Type  Injury  
Manufacturer Narrative
This has an extremely rare occurrence and this type of failure is caused by use error of the product either when placing the device (over-rotation) and/or upon removing the device (under-rotation). Clinical innovations is trying to get more information regarding the incident.
 
Event Description
On the (b)(6) 2017, a caput electrode was placed during the delivery for fetal monitoring of the baby. However, during the removal of the electrode, a piece of metal of this electrode remained stuck under the skin of the baby's head. This has been proven 20 days afterwards through a radiological examination, because of a painful swelling on the head. The broken part has been surgically removed afterwards. Initially another supplier was notified in this case. After investigation, it appeared however that a scalp electrode of bma (scalp electrode goldtrace) is concerned. The complaint relates to the scalp electrode with reference number cns000004. Because this incident was only diagnosed later on, it is not clear which lot number exactly is concerned. The lot numbers being in the hospital at the time of the signaling are 170714 and 170341.
 
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Brand NameGOLDTRACE FETAL SPIRAL ELECTRODE
Type of DeviceFETAL SCALP 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 Key7106754
MDR Text Key94479796
Report Number1722684-2017-00006
Device Sequence Number1
Product Code HGP
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K030691
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,user faci
Reporter Occupation
Remedial Action Patient Monitoring
Type of Report Initial,Followup
Report Date 11/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/11/2019
Device Model NumberCNS000004
Device Lot Number170714
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 Received11/01/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/05/2017
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: 12/11/2017 Patient Sequence Number: 1
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