MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-12 for GOLDTRACE FETAL SCALP ELECTRODE CNS000004 manufactured by Clinical Innovations, Llc.
[120098918]
Whenever there is a break in the skin, there is a risk for infection. The vagina is not a sterile environment, and infection can often develop because of this. There can also be an increased chance of infection depending on how long the fetal scalp electrode is in place during labor. Also information was provided that one child required stitches to repair a place on the baby's scalp that was bleeding after the scalp electrode was removed at delivery. Some of the factors that can contribute to this are: the scalp electrode was not placed and/or removed per our ifu's. The electrode placed in an incorrect location on the baby's scalp. The baby have any clotting or bleeding disorders that could have contributed to the bleeding.
Patient Sequence No: 1, Text Type: N, H10
[120098919]
The goldtrace electrodes have at multiple occasions caused unusually difficult marks in the scalp in recent months. The blood flow where the electrode was stuck had to be sewn on one of the children. And 2 children have had an infection that led to an abscess. The abscess had to be opened and the child has received an antibiotic cure. Other causes of blood flow and inflammation have not been found.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722684-2018-00013 |
| MDR Report Key | 7871562 |
| Date Received | 2018-09-12 |
| Date of Report | 2018-09-12 |
| Date of Event | 2018-08-24 |
| Date Mfgr Received | 2018-09-04 |
| Date Added to Maude | 2018-09-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. SANTOSH BHAGAT |
| Manufacturer Street | 747 W 4170 S |
| Manufacturer City | MURRAY UT 84123 |
| Manufacturer Country | US |
| Manufacturer Postal | 84123 |
| Manufacturer Phone | 8012688200 |
| Manufacturer G1 | CLINICAL INNOVATIONS, LLC |
| Manufacturer Street | 747 W 4170 S |
| Manufacturer City | MURRAY UT 84123 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84123 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GOLDTRACE FETAL SCALP ELECTRODE |
| Generic Name | SPIRAL FETAL SCALP ELECTRODE |
| Product Code | HGP |
| Date Received | 2018-09-12 |
| Model Number | CNS000004 |
| Lot Number | UKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CLINICAL INNOVATIONS, LLC |
| Manufacturer Address | 747 W 4170 S MURRAY UT 84123 US 84123 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-09-12 |