MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-21 for BIOZORB MARKER F0304 manufactured by Focal Theraputics.
| Report Number | 3009718212-2019-00001 |
| MDR Report Key | 8918564 |
| Date Received | 2019-08-21 |
| Date of Report | 2019-08-21 |
| Date of Event | 2019-07-25 |
| Date Mfgr Received | 2019-07-25 |
| Date Added to Maude | 2019-08-21 |
| 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. GEORGE MARCEL |
| Manufacturer Street | 1010 STEWART DRIVE |
| Manufacturer City | SUNNYVALE CA 94085 |
| Manufacturer Country | US |
| Manufacturer Postal | 94085 |
| Manufacturer Phone | 4089627003 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BIOZORB MARKER |
| Generic Name | MARKER, RADIOGRAPHIC, IMPANTABLE |
| Product Code | NEU |
| Date Received | 2019-08-21 |
| Model Number | F0304 |
| Lot Number | PENDING |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FOCAL THERAPUTICS |
| Manufacturer Address | SUNNYVALE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-08-21 |