MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-08-20 for TRUCLEAR 7210165 manufactured by Mitg - Oklahoma City.
| Report Number | 1643264-2019-20017 |
| MDR Report Key | 8911486 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-08-20 |
| Date of Report | 2019-10-30 |
| Date Mfgr Received | 2019-10-16 |
| Date Added to Maude | 2019-08-20 |
| 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 | LISA HERNANDEZ |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 2034925563 |
| Manufacturer G1 | MITG - OKLAHOMA CITY |
| Manufacturer Street | 75 S. MERIDIAN AVE |
| Manufacturer City | OKLAHOMA CITY OK 73107 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 73107 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRUCLEAR |
| Generic Name | INSUFFLATOR, HYSTEROSCOPIC |
| Product Code | HIG |
| Date Received | 2019-08-20 |
| Returned To Mfg | 2019-08-05 |
| Model Number | 7210165 |
| Catalog Number | 7210165 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MITG - OKLAHOMA CITY |
| Manufacturer Address | 75 S. MERIDIAN AVE OKLAHOMA CITY OK 73107 US 73107 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-20 |