MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-14 for GOLD TRACE FETAL SCALP ELECTRODE CNS000004 manufactured by Clinical Innovations, Llc.
[117129086]
It is very important for the fse to be applied correctly to have the best results of monitoring and removal at the end of delivery. It is imperative that the fse not be rotated more than 1? Turn when applying it to the baby's scalp. If the electrode is excessively torqued during (e. G. Rotated > 1? Turns clockwise) application to the presenting part or if the electrode was rotated in the incorrect direction when removing from the scalp. The instructions for removal of the fse in the ifu reads as follows: "remove spiral needle by grasping electrode wires as close to fetal presenting part as possible and twist counter-clockwise until free from presenting part". When removing the fse, it is very important to make sure that the clinicians are twisting it counter-clockwise as close to the presenting part, as possible. If it was inserted correctly, it should not take more than a 1? Turn to remove it. Education on proper insertion and removal along with reviewing of the ifu's are very important for any clinician using this product.
Patient Sequence No: 1, Text Type: N, H10
[117129087]
Information from the parents: a scalp electrode was applied on the scalp of my child. Because of bradycardia during contractions. Need to monitoring risk of fetal hypoxia. The (b)(6) 2018 (d12), a sudden tumefaction of 2cm appeared on the occipital part with, at the summit, a small crust corresponding to the electrode positioning. The (b)(6) 2018 (d16), the tumefaction is bigger (2,5 cm) with a purulent flow. Diagnosis: under skin abscess with staphylococcus inoculated by scalp electrode monitoring per partum. Broken fetal scalp electrode under the skin caused tumefaction with a purulent flow.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722684-2018-00010 |
| MDR Report Key | 7781977 |
| Date Received | 2018-08-14 |
| Date of Report | 2018-08-10 |
| Date of Event | 2019-01-19 |
| Date Mfgr Received | 2018-07-11 |
| Date Added to Maude | 2018-08-14 |
| 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 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 | GOLD TRACE FETAL SCALP ELECTRODE |
| Generic Name | FETAL SCALP ELECTRODE |
| Product Code | HGP |
| Date Received | 2018-08-14 |
| Model Number | CNS000004 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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. Hospitalization; 2. Required No Informationntervention | 2018-08-14 |