MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-28 for DEROYAL NOT PROVIDED manufactured by Ortho And Surgical Products Enterprises S.a..
| Report Number | 3010452421-2019-00002 |
| MDR Report Key | 9246283 |
| Date Received | 2019-10-28 |
| Date of Report | 2019-10-14 |
| Date of Event | 2019-09-05 |
| Date Mfgr Received | 2019-10-14 |
| Date Added to Maude | 2019-10-28 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. MELISSA LOGSDON |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653626157 |
| Manufacturer G1 | ORTHO AND SURGICAL PRODUCTS ENTERPRISES S.A. |
| Manufacturer Street | KM 20.5 CARRETERA A VILLA CANALES |
| Manufacturer City | VILLA CANALES, 01065 |
| Manufacturer Country | GT |
| Manufacturer Postal Code | 01065 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DEROYAL |
| Generic Name | LIMB HOLDER |
| Product Code | FMQ |
| Date Received | 2019-10-28 |
| Model Number | NOT PROVIDED |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHO AND SURGICAL PRODUCTS ENTERPRISES S.A. |
| Manufacturer Address | KM 20.5 CARRETERA A VILLA CANALES VILLA CANALES, 01065 GT 01065 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-10-28 |