MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a study report with the FDA on 2020-03-16 for CYMEDICA ORTHOPEDICS? E-VIVE? CY-1000-216 manufactured by Cymedica Orthopedics, Inc..
| Report Number | 3011466827-2020-00001 |
| MDR Report Key | 9835882 |
| Report Source | STUDY |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-02-21 |
| Date Facility Aware | 2020-02-25 |
| Report Date | 2020-02-25 |
| Date Reported to Mfgr | 2020-02-25 |
| Device Manufacturer Date | 2019-12-17 |
| Date Added to Maude | 2020-03-16 |
| 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 | MS. JACKIE CLEMONS |
| Manufacturer Street | 19120 N. PIMA ROAD SUITE 135 |
| Manufacturer City | SCOTTSDALE, AZ |
| Manufacturer Country | US |
| Manufacturer Phone | 6642547 |
| Manufacturer G1 | CYMEDICA ORTHOPEDICS, INC. |
| Manufacturer Street | 19120 N. PIMA RD., SUITE 135 |
| Manufacturer City | SCOTTSDALE, AZ |
| Manufacturer Country | US |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CYMEDICA ORTHOPEDICS? E-VIVE? |
| Generic Name | E-VIVE? NEUROMUSCULAR ELECTRICAL STIMULATION (NMES) SYSTEM |
| Product Code | GZJ |
| Date Received | 2020-03-16 |
| Model Number | CY-1000-216 |
| Catalog Number | CY-1000-216 |
| Lot Number | 1939-007205 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 2 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CYMEDICA ORTHOPEDICS, INC. |
| Manufacturer Address | 19120 N. PIMA ROAD SUITE 135 SCOTTSDALE, AZ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-16 |