MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-11-07 for QCARE Q4 SYS W/CORINZ 20 6464 manufactured by Sage Products Llc.
Report Number | 0001419181-2019-00014 |
MDR Report Key | 9294050 |
Report Source | HEALTH PROFESSIONAL |
Date Received | 2019-11-07 |
Date of Report | 2019-11-07 |
Date of Event | 2019-11-05 |
Date Mfgr Received | 2019-11-05 |
Date Added to Maude | 2019-11-07 |
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. HEATHER SIRIANNI |
Manufacturer Street | 3909 THREE OAKS ROAD |
Manufacturer City | CARY IL 60013 |
Manufacturer Country | US |
Manufacturer Postal | 60013 |
Manufacturer Phone | 8154554700 |
Manufacturer G1 | SAGE PRODUCTS LLC |
Manufacturer Street | 3909 THREE OAKS ROAD |
Manufacturer City | CARY IL 60013 |
Manufacturer Country | US |
Manufacturer Postal Code | 60013 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | QCARE Q4 SYS W/CORINZ 20 |
Generic Name | SUCTION ORAL SWAB |
Product Code | JOL |
Date Received | 2019-11-07 |
Model Number | 6464 |
Catalog Number | 6464 |
Lot Number | UNKNOWN |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | SAGE PRODUCTS LLC |
Manufacturer Address | 3909 THREE OAKS ROAD CARY IL 60013 US 60013 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-11-07 |