FDA Adverse Event
Malfunction
Summary report: N
810NM 1W CLUSTER (5X200MW) ISSUE 1
MDR report key: 18280668
·
Received December 7, 2023
Report
- Report Number
- 3003899624-2023-00011
- Event Type
- Malfunction
- Date Received
- December 7, 2023
- Date of Event
- February 2, 2021
- Report Date
- December 6, 2023
- Manufacturer
- THOR PHOTOMEDICINE LTD
- Product Code
- ILY
- PMA / PMN Number
- K033923
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORT BASED ON ENHANCEMENTS MADE TO THE COMPANY'S COMPLAINT HANDLING PROCESSES. THIS EVENT IS BEING FILED IN ACCORDANCE WITH A CAPA WHICH HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING.
Description of Event or Problem · 0
ACCORDING TO A THERAPIST, ONE PROBE, SERIAL NUMBER (B)(6), FEELS HOT TO PATIENTS OF COLOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 730682 | 810NM 1W CLUSTER (5X200MW) ISSUE 1 | ILY | THOR PHOTOMEDICINE LTD | S2160 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |