MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-25 for ENDOTOOL SUBQ SUBQ VERSIONS 1.7X manufactured by Monarch Medical Technologies.
| Report Number | 3009864844-2020-90001 |
| MDR Report Key | 9877394 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-17 |
| Date of Event | 2018-07-28 |
| Date Mfgr Received | 2019-05-08 |
| Device Manufacturer Date | 2018-05-11 |
| Date Added to Maude | 2020-03-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | MR. BRIAN JOHNSON |
| Manufacturer Street | 4400 STUART ANDREW BLVD |
| Manufacturer City | CHARLOTTE, NC |
| Manufacturer Country | US |
| Manufacturer Phone | 5249660 |
| Manufacturer G1 | MONARCH MEDICAL TECHNOLOGIES |
| Manufacturer Street | 4400 STUART ANDREW BLVD. |
| Manufacturer City | CHARLOTTE, NC |
| Manufacturer Country | US |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOTOOL SUBQ |
| Generic Name | ENDOTOOL SUBQ 1.7X |
| Product Code | NDC |
| Date Received | 2020-03-25 |
| Model Number | SUBQ VERSIONS 1.7X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MONARCH MEDICAL TECHNOLOGIES |
| Manufacturer Address | 4400 STUART ANDREW BLVD CHARLOTTE, NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-25 |