FDA Adverse Event
Injury
Summary report: N
TX2 TISSUE REMOVAL SYSTEM - MICROTIP
MDR report key: 8044916
·
Received November 6, 2018
Report
- Report Number
- 1000135560-2018-00055
- Event Type
- Injury
- Date Received
- November 6, 2018
- Date of Event
- October 9, 2018
- Report Date
- November 6, 2018
- Manufacturer
- TENEX HEALTH, INC.
- Product Code
- LFL
- PMA / PMN Number
- K153299
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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, BLISTERS WERE REPORTED ON THE PATIENT'S SKIN NEAR THE TREATMENT SITE. THE DOCTOR THOUGHT THEY WERE BURNS CAUSED BY CONTACT WITH PART OF THE MICROTIP DURING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 884451 | TX2 TISSUE REMOVAL SYSTEM - MICROTIP | INSTRUMENT, ULTRASONIC SURGICAL | LFL | TENEX HEALTH, INC. | 554-2003-001 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |