MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-07-05 for GEN CASEFRAME OPTICAL 230V OE3000A/2 manufactured by Orthofix Srl.
| Report Number | 9680825-2019-00045 |
| MDR Report Key | 8763996 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2019-07-05 |
| Date of Report | 2019-08-02 |
| Date of Event | 2019-04-16 |
| Date Mfgr Received | 2019-07-17 |
| Date Added to Maude | 2019-07-05 |
| 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. ROBERTO DONADELLO |
| Manufacturer Street | VIA DELLE NAZIONI, 9 |
| Manufacturer City | BUSSOLENGO, VERONA, ITALY 37012 |
| Manufacturer Country | IT |
| Manufacturer Postal | 37012 |
| Manufacturer G1 | ORTHOFIX SRL |
| Manufacturer Street | VIA DELLE NAZIONI, 9 |
| Manufacturer City | BUSSOLENGO, VERONA, 37012 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 37012 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GEN CASEFRAME OPTICAL 230V |
| Generic Name | GEN CASEFRAME OPTICAL 230V |
| Product Code | JDX |
| Date Received | 2019-07-05 |
| Returned To Mfg | 2019-07-15 |
| Model Number | OE3000A/2 |
| Catalog Number | OE3000A/2 |
| Lot Number | 2G127 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHOFIX SRL |
| Manufacturer Address | VIA DELLE NAZIONI, 9 BUSSOLENGO, VERONA, 37012 IT 37012 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-07-05 |