MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-23 for TX1 TISSUE REMOVAL SYSTEM - MICROTIP 554-1003-001 manufactured by Tenex Health, Inc..
| Report Number | 1000135560-2020-00017 |
| MDR Report Key | 9869573 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-02-27 |
| Date Mfgr Received | 2020-02-27 |
| Date Added to Maude | 2020-03-23 |
| 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 | MR. CHANDLER ROBINSON |
| Manufacturer Street | 2706 BIGHORN AVE STE D |
| Manufacturer City | CODY, WY |
| Manufacturer Country | US |
| Manufacturer Phone | 7609579 |
| Manufacturer G1 | TENEX HEALTH, INC. |
| Manufacturer Street | 26902 VISTA TERRACE |
| Manufacturer City | LAKE FOREST, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TX1 TISSUE REMOVAL SYSTEM - MICROTIP |
| Generic Name | INSTRUMENT, ULTRASONIC SURGICAL |
| Product Code | LFL |
| Date Received | 2020-03-23 |
| Model Number | 554-1003-001 |
| Catalog Number | 554-1003-001 |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TENEX HEALTH, INC. |
| Manufacturer Address | 26902 VISTA TERRACE LAKE FOREST, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-23 |