MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-06-27 for ENDOTOOL IV WEB IV SOFTWARE VERSION 1.8.6 manufactured by Monarch Medical Technologies.
| Report Number | 3009864844-2019-00002 |
| MDR Report Key | 8742385 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-06-27 |
| Date of Report | 2019-06-27 |
| Date of Event | 2017-12-15 |
| Date Mfgr Received | 2017-12-15 |
| Device Manufacturer Date | 2017-07-01 |
| Date Added to Maude | 2019-06-27 |
| 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 | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. BRUCE LISANTI |
| Manufacturer Street | 2137 SOUTH BLVD. SUITE 300 |
| Manufacturer City | CHARLOTTE NC 28203 |
| Manufacturer Country | US |
| Manufacturer Postal | 28203 |
| Manufacturer Phone | 8553637475 |
| Manufacturer G1 | MONARCH MEDICAL TECHNOLOGIES |
| Manufacturer Street | 2137 SOUTH BLVD SUITE 300 |
| Manufacturer City | CHARLOTTE NC 28203 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 28203 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOTOOL IV |
| Generic Name | ENDOTOOL IV |
| Product Code | NDC |
| Date Received | 2019-06-27 |
| Model Number | WEB IV SOFTWARE VERSION 1.8.6 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MONARCH MEDICAL TECHNOLOGIES |
| Manufacturer Address | 2137 SOUTH BLVD. SUITE 300 CHARLOTTE NC 28203 US 28203 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-06-27 |