MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-29 for GOLD TRACE FETAL SCALP ELECTRODE CSN000004 manufactured by Clinical Innovations, Llc.
[125431566]
Clinical innovations learned through our distributor of this event that happened in 2015. Our distributor received a letter from the hospital where the event happened that was dated (b)(6) 2018. We are trying to gather more information if any is available.
Patient Sequence No: 1, Text Type: N, H10
[125431567]
Use of goldtrace fse claimed to have permanently caused tissue damage to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722684-2018-00014 |
| MDR Report Key | 8016924 |
| Date Received | 2018-10-29 |
| Date of Report | 2018-10-24 |
| Date of Event | 2015-08-25 |
| Date Added to Maude | 2018-10-29 |
| 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 | GOLD TRACE FETAL SCALP ELECTRODE |
| Generic Name | FETAL SCALP ELECTRODE |
| Product Code | HGP |
| Date Received | 2018-10-29 |
| Model Number | CSN000004 |
| Lot Number | UKNOWN |
| 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 | 2018-10-29 |