MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-29 for S-CATH CS-2001 manufactured by Circa Scientific, Llc.
| Report Number | 8835787 |
| MDR Report Key | 8835787 |
| Date Received | 2019-07-29 |
| Date of Report | 2019-06-19 |
| Date of Event | 2019-06-19 |
| Report Date | 2019-06-28 |
| Date Reported to FDA | 2019-06-28 |
| Date Reported to Mfgr | 2019-07-26 |
| Date Added to Maude | 2019-07-29 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | S-CATH |
| Generic Name | THERMOMETER, ELECTRONIC, CLINICAL |
| Product Code | FLL |
| Date Received | 2019-07-29 |
| Catalog Number | CS-2001 |
| Lot Number | 13588-01 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CIRCA SCIENTIFIC, LLC |
| Manufacturer Address | 14 IVERNESS DR EAST STE H-136 ENGLEWOOD CO 80112 US 80112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-07-29 |