SCULPSURE
Received Mar 22, 2024 · Event occurred Feb 16, 2024
Report 1222993-2024-00011 · MDR key 18958597
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
66 YR · Female
- Erythema
- Swelling/ Edema
- Erythema
- Swelling/ Edema
Narrative
Description of Event or Problem
IT WAS REPORTED THAT PATIENT EXPERIENCED ERYTHEMA AND EDEMA ON THE OUTER THIGH AREA FOLLOWING A NONINVASIVE LASER LIPOLYSIS TREATMENT USING SCULPSURE. PATIENT ALSO REPORTS THAT THE TREATMENT AREA IS TENDER TO TOUCH 6 DAYS POST TREATMENT.
Additional Manufacturer Narrative
THE DEVICE HISTORY RECORD CONFIRMS THAT THE PRODUCT PASSED AND MET ALL REQUIREMENTS BEFORE RELEASING. PATIENT HAS A HISTORY DIAGNOSIS OF SCLERODERMA, AN AUTOIMMUNE DISEASE THAT CAUSES INFLAMMATION AND FIBROSIS IN THE SKIN AND OTHER AREAS OF THE BODY. CYNOSURE'S CLINICAL TEAM WAS UNABLE TO DETERMINE IF PATIENT'S AUTOIMMUNE DISEASE CONTRIBUTED TO SYMPTOMS EXPERIENCED. ROOT CAUSE IS UNKNOWN AND SINCE THERE IS NO ISSUES WITH THE DEVICE PRODUCTION RECORDS AND CLINICAL INVESTIGATION WAS INCONCLUSIVE, CYNOSURE WILL CONTINUE TO MONITOR SUCH COMPLAINTS. BASED ON THE LABELING MATERIALS AND RISK REVIEW, ERYTHEMA AND EDEMA ARE EXPECTED SIDE EFFECTS FROM SUCH TREATMENTS. PATIENT WAS PRESCRIBED PREDNISONE AS INTERVENTION. THIS IS A REPORTABLE ADVERSE EVENT DUE TO PATIENT RECEIVING MEDICAL INTERVENTION.