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U.S. Department of Health and Human Services

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

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CLINICAL INNOVATIONS, LLC GOLDTRACE FETAL SCALP ELECTRODE FETAL SPIRAL ELECTRODE Back to Search Results
Model Number CNS00004
Device Problem Human Factors Issue (2948)
Patient Problems Unspecified Infection (1930); Device Embedded In Tissue or Plaque (3165)
Event Date 11/17/2017
Event Type  Malfunction  
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 infomration regarding the incident.

 
Event Description

Hospital narrative translated to english: "in the last two weeks we had complications with the scalp electrode: -1x winding left with infection - 1x laceration of the skin after removing. In general we all have the impression that the scalp electrodes are very difficult to detach. It is for example after a caesarean section often not possible to remove the electrode by pulling apart the threads. The nurses also have the feeling that the spiral is longer than before. The lot number of these electrodes is 170347. We would like to receive your reaction to this. Can you also let us know if it is correct that the spiral is now longer than in the past? do you have an instruction to remove correctly the scalp electrode? maybe the customer can learn from that for the future".

 
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Brand NameGOLDTRACE FETAL SCALP ELECTRODE
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 Key7106760
MDR Text Key94817057
Report Number1722684-2017-00011
Device Sequence Number1
Product Code HGP
Combination Product (Y/N)N
Reporter Country CodeSW
PMA/PMN NumberK030691
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,Followup
Report Date 11/12/2018
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 HEALTH PROFESSIONAL
Device EXPIRATION Date06/09/2019
Device MODEL NumberCNS00004
Device LOT Number170347
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/17/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/03/2017
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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