MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-09 for OPTOWIRE III F1032 manufactured by Opsens.
| Report Number | 3008061490-2020-00001 |
| MDR Report Key | 9805197 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-09 |
| Date of Report | 2020-02-13 |
| Date of Event | 2020-02-13 |
| Date Mfgr Received | 2020-02-13 |
| Device Manufacturer Date | 2019-12-10 |
| Date Added to Maude | 2020-03-09 |
| 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. MARC DUGAS |
| Manufacturer Street | 750, BLVD PARC TECHNOLOGIQUE |
| Manufacturer City | QUEBEC, QUEBEC G1P 4S3 |
| Manufacturer Country | CA |
| Manufacturer Postal | G1P 4S3 |
| Manufacturer G1 | OPSENS |
| Manufacturer Street | 750, BLVD PARC TECHNOLOGIQUE |
| Manufacturer City | QUEBEC, QUEBEC G1P 4S3 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | G1P 4S3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTOWIRE III |
| Generic Name | PRESSURE GUIDEWIRE |
| Product Code | DXO |
| Date Received | 2020-03-09 |
| Returned To Mfg | 2020-02-13 |
| Model Number | F1032 |
| Catalog Number | F1032 |
| Lot Number | OW-2012B |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OPSENS |
| Manufacturer Address | 750, BLVD PARC TECHNOLOGIQUE QUEBEC, QUEBEC G1P 4S3 CA G1P 4S3 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-09 |