MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-12-28 for FETAL SPIRAL ELECTRODE UKNOWN manufactured by Clinical Innovations, Llc.
[131615142]
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. This event is being reported retroactively. Though the event reported does not meet the definition of "serious" injury/illness, the possibility of an infection is not remote. Infection itself does not meet the definition of "serious" injury/illness, but it can, in very remote cases, lead to sepsis, which could potentially be a life-threatening illness. At this time, clinical innovations has decided to report any fse-related event indicating infection, suspected infection, or even swelling and redness which required treatment (i. E. Antibiotics, cleaning, suturing, incision) as "other serious (important medical events)" in the united states. No further information is available regarding this event, but clinical innovations continues to monitor and trend all fse related events. "
Patient Sequence No: 1, Text Type: N, H10
[131615143]
The fse spiral tip broke during operation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722684-2018-00020 |
| MDR Report Key | 8202869 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-12-28 |
| Date of Report | 2018-12-27 |
| Date Mfgr Received | 2018-06-15 |
| Date Added to Maude | 2018-12-28 |
| 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 | FETAL SPIRAL ELECTRODE |
| Generic Name | FETAL SPIRAL ELECTRODE |
| Product Code | HGP |
| Date Received | 2018-12-28 |
| Model 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. Other | 2018-12-28 |