FDA Adverse Event
Injury
Summary report: N
TENEX HEALTH TX SYSTEM - WITH TXP MICROTIP
MDR report key: 8182848
·
Received December 19, 2018
Report
- Report Number
- 1000135560-2018-00064
- Event Type
- Injury
- Date Received
- December 19, 2018
- Date of Event
- December 7, 2018
- Report Date
- December 19, 2018
- Manufacturer
- TENEX HEALTH, INC.
- Product Code
- LFL
- PMA / PMN Number
- K181367
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED TO TENEX. A FOLLOW-UP REPORT WILL BE FILED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
FOLLOWING A PROCEDURE WITH THE TENEX HEALTH TX SYSTEM, A MINOR BURN OF 3-4MMIN DIAMETER WAS REPORTED ON THE PATIENT'S SKIN NEAR THE TREATMENT SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1020556 | TENEX HEALTH TX SYSTEM - WITH TXP MICROTIP | INSTRUMENT, ULTRASONIC SURGICAL | LFL | TENEX HEALTH, INC. | 557-1002-001 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Other |