Profound System, Packaged FG70514Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07290109952444), received between Aug 2, 2018 and Dec 9, 2021 — classified as 4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER IN (B)(6) REPORTED THAT A (B)(6) FEMALE PATIENT WITH FITZPATRICK SKIN TYPE 3 HAD "SKIN TIGHTENING" TO HER "LOWER FACE AND NECK" WITH THE PROFOUND SYSTEM, USING THE DERMAL APPLICATOR ON (B)(6) 2021. NO TEST SPOT WAS PERFORMED. CUSTOMER REPORTED THAT "THE TREATMENT WAS TOLERATED WELL AND PROPER SKIN CARE WAS GIVEN TO PATIENT." PER 5-DAY FOLLOW-UP CALL, PATIENT "HAS SOME BRUISES AND SWELLING." THREE WEEKS POST PROFOUND TREATMENT, THE PATIENT WAS SEEN IN THE OFFICE FOR BOTOX; PATIENT MENTIONED "SHE FEELS A BIT OF ASYMMETRY ON LOWER LIP" AND THAT IT HAD APPEARED "AFTER ONE WEEK." THE DOCTOR NOTED "SUBTLE CHANGES PRESENT." ONE MONTH POST TREATMENT, 10 DAYS FOLLOWING BOTOX, THE DOCTOR NOTED LIP ASYMMETRY WHEN SMILING AS WELL AS EYEBROW ASYMMETRY AND PRESCRIBED PREDNISONE "50 MG POOD [SIC] (50 MG 1WK, 25 MG 1WK, AND TAPER THE WEEK AFTER)." THE PATIENT EMAILED THE DOCTOR ABOUT TWO MONTHS POST TREATMENT AND MENTIONED "CHANGES ON LIP AND EYE BROW HAVE PERSISTED." THE PATIENT WAS OUT OF THE COUNTRY, SAYING SHE WILL BE BACK IN TWO MONTHS "(AROUND NOVEMBER)." CUSTOMER REPORTED THAT THE PATIENT DECLINED CONSENT TO SHARE PHOTOS WITH CANDELA. ON NOVEMBER 17, 2021, CANDELA RECEIVED NEW IN

  Patient problems: Nerve Damage

  MAUDE report 12972122 ↗
• InjuryMar 27, 2019Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED TO TECHNICAL SERVICE THAT A (B)(6) YEAR OLD FEMALE PATIENT WITH FITZPATRICK SKIN TYPE II- III; POSITIVE FOR SUN EXPOSURE, PRIOR FACIAL SURGERY, AND SCAR TISSUE, RECEIVED PROFOUND TREATMENT ON THE LOWER FACE, SUBMENTUM, AND ANTERIOR AND LATERAL NECK ON (B)(6) 2018. TREATMENT INCLUDED USE OF SUBCUTANEOUS CARTRIDGE, APPLYING 68 DEGREES CELSIUS FOR 4 SECONDS AT A DEPTH OF 6 MM, FOLLOWED BY TREATMENT WITH THE HANDPIECE AT 68 DEGREES CELSIUS FOR 3 SECONDS AT A 4 MM DEPTH. A TOTAL OF 2546 PULSES WERE DELIVERED. PATIENT TOLERATED THE PROCEDURE WELL AND ICE WAS APPLIED. PATIENT REPORTED EXCESSIVE BRUISING, BLEEDING/SEEPING, PUSTULES, PEELING SKIN, AND LATER REPORTED THAT SHE HAD RECEIVED SEVERAL BURNS, WHICH NURSE PRACTITIONER REFERENCED AS A PARTIAL THICKNESS WOUND AND NOT A BURN. THE RIGHT CHEEK MAY HAVE BECOME INFECTED AND LED TO MEDICAL INTERVENTION/PRESCRIBED ANTIBIOTIC CIPRO, WHICH RESULTED IN A SCARRED AREA ON THE RIGHT CHEEK AS OF (B)(6) 2019.

  Patient problems: Bruise/Contusion; Burn(s); Peeling; Scar Tissue

  MAUDE report 8456969 ↗
• InjuryMar 27, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED TO TECHNICAL SERVICE THAT A (B)(6) YEAR OLD FEMALE PATIENT RECEIVED "RADIO FREQUENCY PROFOUND TREATMENT" TO THE FACE AND NECK AREA ON (B)(6) 2019. TREATMENT INCLUDED USE OF DERMAL HANDPIECE; 651 PULSES WERE ADMINISTERED IN TOTAL, SET AT 67 DEGREES CELSIUS FOR A 3 SECOND DURATION AT 3 MM PULSE SPACING ON THE PATIENT. THERE WAS NO IMMEDIATE POST-TREATMENT REACTION. UPON FOUR AND EIGHT WEEK POST-TREATMENT FOLLOW UP, PATIENT HAD DEVELOPED ACNE-LIKE SCARRING OR SKIN PITTING ON HER LOWER FACE AND NECK. THERE WAS NO MEDICAL INTERVENTION, NO MEDICATIONS PRESCRIBED. DOCTOR INDICATES PATIENT WILL NEED LASER RESURFACING.

  Patient problems: Scar Tissue

  MAUDE report 8456148 ↗
• InjuryAug 2, 2018Adverse Event Without Identified Device or Use Problem

  PATIENT HAD PROFOUND TREATMENT ON THE LOWER FACE AND UPPER NECK ON (B)(6) 2018. SETTINGS WERE 67 DEGREES FOR 3 SECONDS. RIGHT FACE: 92 INSERTIONS, LEFT FACE: 84 INSERTIONS, UPPER NECK 51 INSERTIONS (227 TOTAL). A PRP TOPICAL WAS USED AT THE END OF THE PROCEDURE. WHEN PATIENT'S POST INFLAMMATORY HYPERPIGMENTATION WAS DISCOVERED AT ONE MONTH FOLLOW UP APPOINTMENT, A REVLITE 1064 LASER FACIAL WAS OFFERED AND PERFORMED ON (B)(6) 2018.

  Patient problems: Scarring; Skin Discoloration

  MAUDE report 7742096 ↗