MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-25 for SPECTRA OPTIA 10400 manufactured by Terumo Bct.
| Report Number | 1722028-2019-00314 |
| MDR Report Key | 9238974 |
| Date Received | 2019-10-25 |
| Date of Report | 2019-10-25 |
| Date of Event | 2019-10-01 |
| Date Mfgr Received | 2019-11-15 |
| Device Manufacturer Date | 2019-02-27 |
| Date Added to Maude | 2019-10-25 |
| 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 | 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 PLATELET PLASMA |
| Product Code | LKN |
| Date Received | 2019-10-25 |
| Catalog Number | 10400 |
| Lot Number | 1902283330 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2019-10-25 |