SOFWAVE
Received Jun 17, 2026 · Event occurred Apr 29, 2026
Report 3013917867-2026-00002 · MDR key 25541128
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
37 YR · Female
- Superficial (First Degree) Burn
- Hyperpigmentation
Narrative
Additional Manufacturer Narrative
PREFERRED DEPOT BECAME AWARE ON MAY 18, 2026, OF AN ADVERSE EVENT THAT OCCURRED ON APRIL 29, 2026, AT (B)(6). A PATIENT WAS TREATED USING SOFWAVE SYSTEM S/N (B)(6) AND APPLICATOR S/N (B)(6). A BURN WAS REPORTED IN THE TREATMENT AREA, FOLLOWED BY HYPERPIGMENTATION. MEDICAL INTERVENTION WAS PROVIDED BY THE TREATING PHYSICIAN. PREFERRED DEPOT RECEIVED NOTIFICATION FROM THE MANUFACTURER THAT THE EVENT HAD BEEN DETERMINED TO BE REPORTABLE TO FDA.
Description of Event or Problem
PREFERRED DEPOT BECAME AWARE ON MAY 18, 2026, OF AN ADVERSE EVENT THAT OCCURRED ON APRIL 29, 2026, AT (B)(6). A PATIENT UNDERWENT TREATMENT USING SOFWAVE SYSTEM S/N (B)(6) AND APPLICATOR S/N (B)(6). A BURN WAS REPORTED IN THE TREATMENT AREA FOLLOWING TREATMENT. HYPERPIGMENTATION WAS SUBSEQUENTLY REPORTED, AND MEDICAL INTERVENTION WAS PROVIDED. ON MAY 18, 2026, PREFERRED DEPOT RECEIVED NOTIFICATION FROM THE MANUFACTURER THAT THE EVENT WAS DETERMINED TO BE REPORTABLE TO FDA.
Remedial action
- Replace