Profound system FG70513Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290109950792), received between Jun 8, 2018 and Dec 17, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 17, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  A SPOUSE REPORTED THAT THE PATIENT HAD A PROFOUND TREATMENT PERFORMED AT A PLASTIC SURGEON'S OFFICE IN (B)(6) AND EXPERIENCED AN ADVERSE EVENT. THE REPORTER STATED THAT THE PROCEDURE TOOK PLACE ON (B)(6) 2024, THE PATIENT WAS "PLACED UNDER GENERAL ANESTHESIA FOR THE PROFOUND RF TREATMENT OF THE UPPER ARMS AND STOMACH AREA. IMMEDIATELY UPON WAKING UP FROM GENERAL ANESTHESIA, HANDS WERE NUMB/PAINFUL. THE STOMACH AREA WAS NOT. WAS LATER TOLD BY A NURSE THAT WAS THERE DURING THE PROCEDURE THAT HANDS WERE REACTIVE DURING THE PROCEDURE. IT'S NOW APPROXIMATELY ONE MONTH SINCE THE TREATMENT AND THE CONDITION HAS WORSENED, EXTREME RELENTLESS PAIN, NUMBNESS AND LACK OF FINGER/HAND MOBILITY. CAN'T USE PHONE, COMPUTER AND TOTALLY LIMITED IN ANYTHING THAT INVOLVES HANDS, ARMS. HAVE BEEN TO SEVERAL DOCTORS/CARE PROVIDERS INCLUDING PAIN MANAGEMENT AND NEUROLOGIST. HAVE ALSO BEEN TO A HOSPITAL EMERGENCY ROOM TWICE SINCE THE PROCEDURE DUE TO THE EXTREME PAIN, NUMBNESS AND LACK OF FINGER/HAND MOBILITY. DAY TO DAY LIFE HAS COME TO A COMPLETE HALT SINCE THE PROCEDURE." CANDELA RECEIVED ADDITIONAL INFORMATION FROM THE REPORTER, THE REPORTER CONFIRMED THAT THE PATIENT WAS TREATED USING THE PROFOUND DEVI

  Patient problems: Limb Pain; Nerve Damage; Numbness

  MAUDE report 20955278 ↗
• InjuryJun 8, 2018Patient-Device Incompatibility

  ON (B)(6) 2018, SYNERON WAS MADE AWARE OF CLINICAL COMPLAINT REGARDING HYPERPIGMENTATION AND SCARS FOLLOWING TREATMENT WITH PROFOUND DEVICE AND DERMAL APPLICATOR. THE CUSTOMER IS DR. (B)(6). FEMALE 40 YEARS OLD WITH SKIN TYPE III, CAUCASIAN ETHNICITY, UNDERWENT PROFOUND TREATMENT USING DERMAL APPLICATOR ON (B)(6) 2018. THE TREATMENT AREA WAS FACE. NO COMPLAINTS WERE DURING TREATMENT, AFTER THE TREATMENT FINISHED THE PATIENT GOT ACUTE ALLERGY TO RF AND WAS IMMEDIATELY TREATED WITH STEROID. PHOTOS THAT WERE RECEIVED FROM THE CUSTOMER AROUND MONTH AFTER THE TREATMENT SHOW HYPERPIGMENTATION AND SCARS ON THE TREATMENT AREA.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 7584259 ↗