MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-12-21 for GOLDTRACE FETAL SCALP ELECTRODES CNS000004 manufactured by Clinical Innovations, Llc.
[131222252]
The device was discarded; the lot number is not known. No further information will be made available but clinical innovations will continue to monitor and trend all reported events associated with this device.
Patient Sequence No: 1, Text Type: N, H10
[131222253]
Problems removing the fetal scalp electrodes. According to the midwifes the scalp electrodes seems more tight than previous batch. Device caused big bald spots after placing the scalp electrodes three-times. They saw 5 babies with inflammations due to scalp electrodes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722684-2018-00019 |
| MDR Report Key | 8191387 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-12-21 |
| Date of Report | 2018-12-21 |
| Date Mfgr Received | 2018-12-05 |
| Date Added to Maude | 2018-12-21 |
| 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 | MS. ANDREA GADSBY |
| 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 | 3 |
| Brand Name | GOLDTRACE FETAL SCALP ELECTRODES |
| Generic Name | FETAL SCALP ELECTRODES |
| Product Code | HGP |
| Date Received | 2018-12-21 |
| Model Number | CNS000004 |
| 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. Other | 2018-12-21 |