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.
[120099257]
This particular patient required 2 separate fetal scalp electrodes to be placed due to lack of connectivity. Sometimes, if the first electrode is not applied securely enough or if the baby has a large amount of hair, it can interfere with the connectivity. Approximately, 3 days after delivery, the baby developed an infection on the scalp where the electrodes had been placed. Unfortunately, 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.
Patient Sequence No: 1, Text Type: N, H10
[120099258]
Spontaneous partus (b)(6) 2018, in which two times a new scalp electrode was placed because of bad registration. On (b)(6) consultation in pediatrics concerning inflated swelling on the occiput of the neonate. Ultrasound was done: no corpus alienum, but pus visible. Infection treated with antibiotics.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722684-2018-00012 |
| MDR Report Key | 7871563 |
| Date Received | 2018-09-12 |
| Date of Report | 2018-09-11 |
| Date of Event | 2018-02-06 |
| 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 |
| 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 |