MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-11-06 for REN? TRANSORAL NEEDLE 12-000-00-ND1 manufactured by Cytophil, Inc..
| Report Number | 3007225376-2019-00004 |
| MDR Report Key | 9287127 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-11-06 |
| Date of Report | 2019-11-06 |
| Date of Event | 2019-09-27 |
| Date Mfgr Received | 2019-10-08 |
| Device Manufacturer Date | 2019-04-23 |
| Date Added to Maude | 2019-11-06 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. KRISTIE SOTO |
| Manufacturer Street | 2485 CORPORATE CIRCLE SUITE 2 |
| Manufacturer City | EAST TROY WI 53120 |
| Manufacturer Country | US |
| Manufacturer Postal | 53120 |
| Manufacturer Phone | 2626422765 |
| Manufacturer G1 | CYTOPHIL, INC. |
| Manufacturer Street | 2485 CORPORATE CIRCLE SUITE 2 |
| Manufacturer City | EAST TROY WI 53120 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53120 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REN? TRANSORAL NEEDLE |
| Generic Name | NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE |
| Product Code | GAA |
| Date Received | 2019-11-06 |
| Model Number | 12-000-00-ND1 |
| Catalog Number | 12-000-00-ND1 |
| Lot Number | Q912-00031 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CYTOPHIL, INC. |
| Manufacturer Address | 2485 CORPORATE CIRCLE SUITE 2 EAST TROY WI 53120 US 53120 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-11-06 |