ULTRACLEAR
Report
- Report Number
- 3021550489-2024-00001
- Event Type
- Death
- Date Received
- February 9, 2024
- Date of Event
- January 26, 2024
- Report Date
- February 9, 2024
- Manufacturer
- ACCLARO CORPORATION
- Product Code
- GEX
- PMA / PMN Number
- K210847
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- 501
Narratives
BASED ON THE INFORMATION PROVIDED BY THE MEDICAL DIRECTOR OF ONE OF OUR CLIENTS, A PHYSICIAN WITHIN THE PRACTICE TREATED A PATIENT ON (B)(6) 2024. THIS PATIENT LATER WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2024, FOR REASONS UNKNOWN AT THIS POINT. THE PATIENT PASSED AWAY ON (B)(6) 2024, AND THE CAUSE OF DEATH IS CURRENTLY UNKNOWN. ON FEBRUARY 8TH, 2024, THE DEVICE USED ON THIS PATIENT WAS COMPLETELY INSPECTED ON-SITE BY A QUALIFIED SERVICE TECHNICIAN, AND THE DEVICE WAS FOUND TO BE FUNCTIONING WITHIN THE DESIGN SPECIFICATIONS AND THERE WAS NO SIGN OF ANY MALFUNCTION. AT THIS TIME, THERE IS NO INDICATION THAT THE DEATH WAS CAUSED BY THE LASER TREATMENT.
BASED ON THE INFORMATION PROVIDED BY THE MEDICAL DIRECTOR OF ONE OF OUR CLIENTS, A PHYSICIAN WITHIN THE PRACTICE TREATED A PATIENT ON (B)(6) 2024. THIS PATIENT LATER WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2024, FOR REASONS UNKNOWN AT THIS POINT. THE PATIENT PASSED AWAY ON (B)(6) 2024, AND THE CAUSE OF DEATH IS CURRENTLY UNKNOWN. ON FEBRUARY 8TH, 2024, THE DEVICE USED ON THIS PATIENT WAS COMPLETELY INSPECTED ON-SITE BY A QUALIFIED SERVICE TECHNICIAN, AND THE DEVICE WAS FOUND TO BE FUNCTIONING WITHIN THE DESIGN SPECIFICATIONS AND THERE WAS NO SIGN OF ANY MALFUNCTION. AT THIS TIME, THERE IS NO INDICATION THAT THE DEATH WAS CAUSED BY THE LASER TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 68864 | ULTRACLEAR | FRACTIONAL LASER SYSTEM | GEX | ACCLARO CORPORATION | AS-BK-00055 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Female | Hospitalization| D |