MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-27 for ROSA ONE ROSAS00203 manufactured by Medtech Sa.
| Report Number | 3009185973-2020-00100 |
| MDR Report Key | 9887624 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2018-08-13 |
| Date Added to Maude | 2020-03-27 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JAY SHARMA |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal | 32218 |
| Manufacturer Phone | 9047414400 |
| Manufacturer G1 | MEDTECH SA |
| Manufacturer Street | ZAC EUREKA 900 RUE DU MAS DE VERCHANT |
| Manufacturer City | MONTPELLIER, LANGUEDOC-ROUSSILLON 34000 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 34000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROSA ONE |
| Generic Name | COMPUTER-ASSISTED SURGICAL DEVICE |
| Product Code | HAW |
| Date Received | 2020-03-27 |
| Model Number | ROSA ONE |
| Catalog Number | ROSAS00203 |
| Lot Number | 3.1.1.1295 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTECH SA |
| Manufacturer Address | ZAC EUREKA 900 RUE DU MAS DE VERCHANT MONTPELLIER, LANGUEDOC-ROUSSILLON 34000 FR 34000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |