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 ELECTRODE CNS000004 manufactured by Clinical Innovations, Llc.
[131220582]
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. 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
[131220583]
At the delivery ward, swelling was noted on the child's scalp, which was judged to be due to the electrode previously sitting there. The swelling did not recede, and when the child was (b)(6), it was examined through the ultrasound that showed a small metal piece superficially under the skin, about 4x1mm reportedly. The child has no complications but will be followed up at (b)(6) clinic with a view to removing the foreign body by local anesthesia or anesthesia.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722684-2018-00017 |
| MDR Report Key | 8191386 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-12-21 |
| Date of Report | 2018-12-21 |
| Date of Event | 2018-08-15 |
| 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 ELECTRODE |
| Generic Name | FETAL SCALP ELECTRODE |
| 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, |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-21 |