MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-11-26 for SPECTRA OPTIA 12220 manufactured by Terumo Bct.
Report Number | 1722028-2019-00380 |
MDR Report Key | 9376482 |
Report Source | HEALTH PROFESSIONAL |
Date Received | 2019-11-26 |
Date of Report | 2019-11-26 |
Date of Event | 2019-11-07 |
Date Mfgr Received | 2019-11-07 |
Device Manufacturer Date | 2019-08-29 |
Date Added to Maude | 2019-11-26 |
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 | GARY DARK |
Manufacturer Street | 10810 W. COLLINS AVE |
Manufacturer City | LAKEWOOD CO 80215 |
Manufacturer Country | US |
Manufacturer Postal | 80215 |
Manufacturer Phone | 3035425102 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | SPECTRA OPTIA |
Generic Name | SPECTRA OPTIA EXCHANGE SET |
Product Code | LKN |
Date Received | 2019-11-26 |
Catalog Number | 12220 |
Lot Number | 1908273230 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | TERUMO BCT |
Manufacturer Address | LAKEWOOD CO 80215 US 80215 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other; 2. Required No Informationntervention | 2019-11-26 |