MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-30 for NOVA STATSENSOR CREATININE HOSPITAL METER SYSTEM 43370 manufactured by Nova Biomedical Corporation.
[125662019]
Investigation currently in process. No patient adverse event resulted from the adminstration of contrast during ct.
Patient Sequence No: 1, Text Type: N, H10
[125662020]
Discrepant creatinine results on nova stat sensor resulted in adminstration of contrast during ct.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1219029-2018-00004 |
MDR Report Key | 8021303 |
Date Received | 2018-10-30 |
Date of Report | 2018-10-30 |
Date of Event | 2018-10-10 |
Date Mfgr Received | 2018-10-15 |
Device Manufacturer Date | 2018-05-09 |
Date Added to Maude | 2018-10-30 |
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 |
Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MS. TAYLOR WARD |
Manufacturer Street | 200 PROSPECT ST |
Manufacturer City | WALTHAM MA 02453 |
Manufacturer Country | US |
Manufacturer Postal | 02453 |
Manufacturer Phone | 7816473700 |
Manufacturer G1 | NOVA BIOMEDICAL CORPORATION |
Manufacturer Street | 200 PROSPECT STREET |
Manufacturer City | WALTHAM MA 024533465 |
Manufacturer Country | US |
Manufacturer Postal Code | 024533465 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Brand Name | NOVA STATSENSOR CREATININE HOSPITAL METER SYSTEM |
Generic Name | ELECTRODE, ION BASED, ENZYMATIC, CREATININE |
Product Code | CGL |
Date Received | 2018-10-30 |
Returned To Mfg | 2018-10-25 |
Model Number | 43370 |
Lot Number | 4918129129 |
Device Expiration Date | 2019-05-09 |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | NOVA BIOMEDICAL CORPORATION |
Manufacturer Address | 200 PROSPECT STREET WALTHAM MA 024533465 US 024533465 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2018-10-30 |