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 2019-07-02 for NOVII 107-PT-020 manufactured by Monica Healthcare Ltd.
| Report Number | 3006340424-2019-00001 |
| MDR Report Key | 8755274 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-07-02 |
| Date of Report | 2019-11-26 |
| Date of Event | 2019-06-19 |
| Date Mfgr Received | 2019-11-13 |
| Device Manufacturer Date | 1970-01-01 |
| Date Added to Maude | 2019-07-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | JOHN SZALINSKI |
| Manufacturer Street | 3000 N GRANDVIEW BLVD. |
| Manufacturer City | WAUKESHA WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOVII |
| Generic Name | UTERINE ELECTROMYOGRAPHIC MONITOR |
| Product Code | OSP |
| Date Received | 2019-07-02 |
| Model Number | 107-PT-020 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MONICA HEALTHCARE LTD |
| Manufacturer Address | UNIT 8, INTERCHANGE 25 BUSINESS PARK BOSTOCKS LANE NOTTINGHAM NG105QG UK NG10 5QG |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-07-02 |