MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-07-11 for HEMOBLAST BELLOWS BQF02 BQF02-US manufactured by Biom'up Sa.
| Report Number | 3007702492-2019-00002 |
| MDR Report Key | 8781832 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-07-11 |
| Date of Report | 2019-06-20 |
| Date Mfgr Received | 2019-04-08 |
| Date Added to Maude | 2019-07-11 |
| 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. TOM MAGUIRE |
| Manufacturer Street | 8 ALLEE IRENE JOLIOT CURIE |
| Manufacturer City | SAINT-PRIEST, RHONE 69800 |
| Manufacturer Country | FR |
| Manufacturer Postal | 69800 |
| Manufacturer G1 | BIOM'UP SA |
| Manufacturer Street | 8 ALLEE IRENE JOLIOT CURIE |
| Manufacturer City | SAINT-PRIEST, 69800 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 69800 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMOBLAST BELLOWS |
| Generic Name | HEMOSTATIC AGENT |
| Product Code | PMX |
| Date Received | 2019-07-11 |
| Model Number | BQF02 |
| Catalog Number | BQF02-US |
| Lot Number | BQF17030.134149 |
| Device Expiration Date | 2018-12-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOM'UP SA |
| Manufacturer Address | 8 ALLEE IRENE JOLIOT CURIE SAINT-PRIEST, RHONE 69800 FR 69800 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-07-11 |