truSculpt iDRecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00816722021427), received between Jun 7, 2022 and Aug 21, 2026 — classified as 26 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (17 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryAug 21, 2026Adverse Event Without Identified Device or Use Problem

  On (b)(6) 2026, a 61 year old female underwent truSculpt iD treatment to the abdomen using six handpieces. The patient reportedly did not experience pain or excessive heat during treatment. A burn to the lower abdomen was subsequently reported.The available documentation contains an inconsistency regarding when the patient first reported the event to the clinic. One record states that the patient notified the clinic on (b)(6) 2026; however, the clinic had reported the event to Cutera on (b)(6) 2026. Therefore, the date the patient first notified the clinic cannot be confirmed. A photograph of the wound that was provided for review is labeled (b)(6) 2026; however, the date the photograph was taken, the accuracy of the displayed date, and the identity of the person who took the photograph have not been confirmed.The wound in the photo appears aged and to involve full-thickness tissue injury. The patient reportedly underwent wound debridement and treatment with hydrocolloid dressings. As of (b)(6) 2026, the area was reported to be still healing.No device malfunction or abnormal operation was reported in association with the treatment. Preventive maintenance was performed on (b)(6) 202

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 50382143 ↗
• InjuryAug 21, 2026Off-Label Use; Improper or Incorrect Procedure or Method

  On (b)(6) 2026, a 64 year old female underwent truSculpt iD treatment to the bilateral bra-fat and mid-back areas. Return pads were reported to have been placed on the upper back. Following treatment, a blister was noted on the right back at the edge of a return pad electrode. The physician reported applying a hydrocolloid dressing, providing antibiotic cream and RGN 6 cream, and performing debridement. As of (b)(6) 2026, the affected area was reported to be still healing. No device malfunction or abnormal operation was reported. The cause of the event cannot be definitively determined. The separation between the nearest treatment handpiece and return pad was documented as "a couple of inches". The Instructions for Use specify a minimum 4 inch (10 cm) separation when treating near the return pads. The reported separation did not meet this requirement. The mid-back treatment is outside of the identified indication for the 2 MHz setting with the 40 cm2 handpiece.

  Patient problems: Full thickness (Third Degree) Burn; Wound Infection

  MAUDE report 50382137 ↗
• InjuryAug 21, 2026Off-Label Use; Improper or Incorrect Procedure or Method

  On (b)(6) 2026, a 43-year-old female underwent truSculpt iD treatment to the bilateral bra-fat and mid-back areas. Return pads were reported to have been placed on the upper back. Following treatment, a blister was noted at the lower edge of a return pad electrode on one side of the back; a second blister was reported the following day on the opposite side. The affected areas were described as bilateral mid-back burns near the inferior edge of the scapulae. A hydrocolloid dressing was applied, an antibiotic was prescribed, and bandages were provided. As (b)(6) 2026, the areas were reported to be still healing. No device malfunction, abnormal operation, or error messages were reported. The actual distance between the treatment handpieces and return pads could not be confirmed. The Instructions for Use specify a minimum 4-inch (10 cm) separation when treating near the return pads. Insufficient separation cannot be ruled out; however, the cause of the event cannot be definitively determined from the available information. The mid-back treatment is outside of the identified indication for the 2 MHz setting with the 40 cm2 handpiece.

  Patient problems: Full thickness (Third Degree) Burn; Wound Infection

  MAUDE report 50382136 ↗
• InjuryMay 29, 2026Improper or Incorrect Procedure or Method

  BACKGROUND / CASE IDENTIFICATION: IN MAY 2026, CUTERA RECEIVED A CUSTOMER INQUIRY REFERENCING A PREVIOUSLY REPORTED ADVERSE EVENT AND IDENTIFIED A HISTORICAL ADVERSE EVENT REPORT ORIGINALLY RECEIVED IN FEBRUARY 2022. THE INQUIRY DID NOT INCLUDE NEW CLINICAL INFORMATION, AND REASSESSMENT IDENTIFIED NO ADDITIONAL EVENT DETAILS. REPORTED CLINICAL EVENT: BASED ON INFORMATION PROVIDED BY THE CLINIC OWNER/DEVICE OPERATOR, THE PATIENT REPORTEDLY UNDERWENT TRUSCULPT TREATMENT TO THE LOWER ABDOMEN IN (B)(6) 2022. THE PATIENT REPORTEDLY DEVELOPED A BURN WITH BLISTERING THAT PROGRESSED FROM A FLUID-FILLED BLISTER TO AN OPEN WOUND THAT REPORTEDLY DEEPENED AND LATER BECAME INFECTED. REPORTED MEDICAL MANAGEMENT INCLUDED TOPICAL SILVER SULFADIAZINE (SILVADENE), ANTIBIOTIC OINTMENT, AND PROFESSIONAL WOUND CARE, INCLUDING TREATMENT BY A WOUND CARE NURSE AND EVALUATION THROUGH A WOUND CARE CLINIC. THE REPORTED OUTCOME WAS SCAR FORMATION. BASED ON THE REPORTED NEED FOR PROFESSIONAL INTERVENTION, THE EVENT WAS ASSESSED AS MODERATE IN SEVERITY. AVAILABLE INFORMATION: INFORMATION REGARDING TREATMENT PARAMETERS, PROCEDURAL DETAILS, TIMING OF INTERVENTIONS, SCAR DIMENSIONS, DURATION, CURRENT STATUS, AND S

  Patient problems: Partial thickness (Second Degree) Burn; Scar Tissue

  MAUDE report 25337719 ↗
• InjuryMar 12, 2026Improper or Incorrect Procedure or Method

  ADVERSE EVENT DESCRIPTION: A BURN MEASURING APPROXIMATELY 1 IN X 0.5 IN, CHARACTERIZED AS A DEEP DERMAL-TO-FULL-THICKNESS INJURY, WAS OBSERVED ON THE LEFT LOWER ABDOMEN FOLLOWING TREATMENT. THE WOUND SUBSEQUENTLY BECAME INFECTED AND REQUIRED TREATMENT WITH BOTH ORAL AND TOPICAL ANTIBIOTICS. THE WOUND IS LOCATED ON THE LEFT LOWER ABDOMEN IN AN AREA WITH STRIAE AND CURVED TISSUE CONTOURS. THE LESION APPEARS LINEAR IN SHAPE AND MEASURES APPROXIMATELY 1 IN X 0.5 IN. ACCORDING TO THE DEVICE OPERATOR, THE BURN OCCURRED UNDER THE EDGE OF THE HANDPIECE ELECTRODE. PROCEDURE AND TREATMENT INFORMATION: THE DEVICE OPERATOR REPORTED PLACING THREE HANDPIECES ON A SINGLE DECAL DURING TREATMENT. HOWEVER, THE INSTRUCTIONS FOR USE (IFU) SPECIFY A MAXIMUM OF TWO HANDPIECES PER DECAL. THE PATIENT'S BMI WAS NOT DOCUMENTED IN THE TREATMENT RECORD. PATIENT ELIGIBILITY FOR TREATMENT, AS WELL AS HANDPIECE SPACING PARAMETERS, ARE DETERMINED BASED ON BMI. TECHNIQUE AND PATIENT SELECTION CONSIDERATIONS: THE IFU SPECIFIES TREATMENT ONLY FOR CANADIAN PATIENTS WITH BMI >= 20 AND <= 30 AND LIMITS PLACEMENT TO NO MORE THAN TWO HANDPIECES PER DECAL. THE IFU ALSO INSTRUCTS OPERATORS NOT TO PLACE DECALS OVER SCARS OR

  Patient problems: Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn; Scar Tissue

  MAUDE report 24586120 ↗
• InjuryDec 30, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  EVENT SUMMARY: CUTERA RECEIVED A REPORT OF A BURN SUSTAINED BY A 68-YEAR-OLD FEMALE CLIENT (INITIALS (B)(6) SKIN TYPE IV, BMI REPORTED AS "OVERWEIGHT") FOLLOWING A TRUSCULPT HANDS-FREE RADIOFREQUENCY (RF) TREATMENT TO THE LOWER ABDOMEN. CUTERA WAS NOT PRESENT DURING THE CLIENT ASSESSMENT OR TREATMENT. DESCRIPTION OF THE INJURY: THE BURN WAS LOCATED ON THE RIGHT LOWER ABDOMEN IN AN AREA WITH VISIBLE STRETCH MARKS AND CURVED TISSUE. REVIEW OF THE PHOTOGRAPHS SHOWS A LINEAR BURN PATTERN WITH SQUARED EDGES. THIS PATTERN MAY BE CONSISTENT WITH PARTIAL LIFTING OF THE HANDPIECE AND/OR DECAL DURING TREATMENT. LIFTING OF THE HANDPIECE OR DECAL CAN REDUCE SKIN CONTACT AND RESULT IN LOCALIZED INCREASES IN RF ENERGY. EXCESSIVE SWEATING DURING TREATMENT WAS REPORTED, WHICH MAY HAVE FURTHER REDUCED DECAL ADHESION AND CONSISTENT SKIN CONTACT. TREATMENT SETUP CONSIDERATIONS: HANDPIECE SPACING AND THE CLIENT'S NUMERIC BMI WERE NOT DOCUMENTED. AS A RESULT, CUTERA IS UNABLE TO FULLY ASSESS WHETHER HANDPIECE SPACING WAS CONSISTENT WITH TREATMENT GUIDELINES. DEVICE EVALUATION: A FIELD SERVICE EVALUATION WAS PERFORMED ON 2 DECEMBER 2025 (CASE (B)(4) / WORK ORDER (B)(4)). ALL HANDPIECES WERE TESTED AND F

  Patient problems: Burn(s); Full thickness (Third Degree) Burn

  MAUDE report 23927252 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A TRUSCULPT PROCEDURE TARGETING THE LOWER ABDOMEN. FOLLOWING TREATMENT, THE PATIENT DEVELOPED TWO LOCALIZED BURN INJURIES ON THE RIGHT AND LEFT LOWER ABDOMEN IN AREAS CORRESPONDING TO CURVE SKIN SURFACES. ONE BURN MEASURED APPROXIMATELY 1.0 CM X 1.5 CM, AND THE OTHER MEASURED 1.0 CM X 4.0 CM. THE TREATING CLINICIAN PRESCRIBED SILVADENE (SILVER SULFADIAZINE) TOPICAL OINTMENT, ORAL ANTIBIOTICS (BACTRIM), AND GAUZE DRESSINGS FOR WOUND CARE. THE PATIENT REPORTED A PAIN LEVEL OF 2 OUT OF 10 DURING THE PROCEDURE. THE BURNS WERE NOT REPORTED TO THE CLINIC UNTIL THREE WEEKS POST-TREATMENT. ACCORDING TO THE DEVICE OPERATOR, NO UNUSUAL SKIN REACTION WAS OBSERVED DURING OR IMMEDIATELY FOLLOWING THE PROCEDURE. A FIELD SERVICE EVALUATION OF THE TRUSCULPT SYSTEM WAS CONDUCTED AND CONFIRMED THAT THE DEVICE MEETS ALL PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE HAS NOT BEEN DEFINITIVELY IDENTIFIED. HOWEVER, TWO POTENTIAL CONTRIBUTING FACTORS HAVE BEEN IDENTIFIED: 1) HANDPIECE SPACING RELATIVE TO PATIENT BMI: THE BURNS WERE LOCATED IN AREAS WHERE THE HANDPIECES MAY HAVE BEEN PLACED TOO CLOSE TOGETHER. THE TRUSCULPT INSTRUCTIONS FOR USE (IFU) INCLUDE SPECIFIC GUIDANCE REGARDING H

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 23297491 ↗
• InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CLINICAL THAT OWNS THE TRUSCULPT SYSTEM INITIALLY CONTACTED CUTERA TO REQUEST SUGGESTIONS ON WOUND MANAGEMENT OPTIONS TO HELP MINIMIZE THE POTENTIAL RISK OF SCARRING. CUTERA DID NOT PROVIDE MEDICAL ADVICE FOR WOUND CARE MANAGEMENT OR SCAR REDUCTION. THE TREATMENT WAS PERFORMED APPROXIMATELY TWO WEEKS PRIOR TO THE REPORT TO CUTERA. A 48 YEAR OLD FEMALE PATIENT WITH FITZPATRICK SKIN TYPE V UNDERWENT A HANDS-FREE TRUSCULPT PROCEDURE USING SIX HANDPIECES TO THE LOWER ABDOMEN, MID-ABDOMEN, AND BILATERAL FLANKS. TWO RETURN PADS WERE PLACED ON THE UPPER BACK. THE PATIENT DID NOT REPORT PAIN OR DISCOMFORT DURING THE PROCEDURE, AND THE SKIN APPEARED NORMAL UPON REMOVAL OF THE RETURN PADS. THE OPERATOR NOTED A MODERATE AMOUNT OF SWEATING DURING TREATMENT. THE FOLLOWING DAY, THE PATIENT DEVELOPED A BLISTER APPROXIMATELY THE "SIZE OF A QUARTER" AT THE LOWER CORNER OF THE RETURN PAD ELECTRODE. THE CLINIC EXPRESSED CONCERN ABOUT POTENTIAL KELOID FORMATION. THE PATIENT WAS ADVISED TO APPLY AQUAPHOR, KEEP THE SITE COVERED, AND AVOID SUN EXPOSURE; HEALING WAS REPORTED TO BE "SLOW". THERE WERE NO DEVICE MALFUNCTIONS, ERROR CODES, OR PERFORMANCE COMPLAINTS REPORTED. BASED ON AVAILABLE INFORMATION

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 23069670 ↗
• InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ADVERSE EVENT OCCURRED IN JUNE 2023 INVOLVING BURNS TO A PATIENT'S ABDOMEN DURING A TRUSCULPT TREATMENT. AN INVESTIGATION WAS INITIATED AT THAT TIME IN COLLABORATION WITH THE TREATING CLINIC. THE BURNS WERE REPORTED BY THE CLINIC TO BE APPROXIMATELY 80-95% HEALED DURING FOLLOW-UP AND BASED ON CLINICAL ASSESSMENT AND AVAILABLE INFORMATION AT THE TIME, THE INCIDENT WAS NOT DEEMED TO MEET FDA REPORTABILITY CRITERIA. THE DEVICE WAS NOT RETURNED OR EVALUATED, AS THERE WAS NO INDICATION OF A MALFUNCTION OR FAILURE. THE ROOT CAUSE OF THE INCIDENT WAS DETERMINED TO BE USE ERROR. UPDATED INFORMATION: IN MAY 2025, THE CLINIC PROVIDED A FOLLOW-UP PHOTO OF THE TREATED AREA, WHICH SHOWED EVIDENCE OF SCAR FORMATION AT THE SITES OF THE ORIGINAL BURNS. NO NEW OR ONGOING ADVERSE EVENTS HAVE BEEN REPORTED BY THE CLINIC SINCE THE INITIAL INCIDENT IN (B)(6) 2023. CONCLUSION: THE EVENT HAS BEEN REASSESSED IN LIGHT OF THE UPDATED CLINICAL INFORMATION, AND THIS REPORT IS BEING SUBMITTED IN ACCORDANCE WITH FDA REQUIREMENTS. THE DEVICE FUNCTIONED AS INTENDED, AND NO DEVICE-RELATED MALFUNCTION CONTRIBUTED TO THE OUTCOME. THE ROOT CAUSE REMAINS ATTRIBUTED TO USE ERROR.

  Patient problems: Scar Tissue

  MAUDE report 22181031 ↗
• InjuryMay 21, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  AN ADULT FEMALE PATIENT RECEIVED A TRUSCULPT TREATMENT TO THE NECK AREA. AFTER THE PROCEDURE, THE TREATING PHYSICIAN OBSERVED A LINEAR, RAISED, AND FIRM LESION WITH AN UNDERLYING NODULE ON THE ANTERIOR UPPER NECK. THE SKIN REMAINED INTACT, AND THE LESION WAS DESCRIBED AS A HORIZONTAL LINE. THE PHYSICIAN NOTED THAT THE LESION DID NOT APPEAR TO BE A BURN. THE PATIENT DECLINED A FULL CLINICAL EVALUATION AND DID NOT PROVIDE DETAILS ABOUT WHEN THE SKIN CHANGES BEGAN. HOWEVER, SHE REQUESTED ANTIBIOTIC TREATMENT, AND THE PHYSICIAN PRESCRIBED BACTRIM DS (TAKEN ORALLY TWICE DAILY FOR 7 DAYS). THE PATIENT ALSO VISITED AN URGENT CARE CLINIC, WHERE SHE WAS PRESCRIBED TRIAMCINOLONE CREAM. THE PHYSICIAN DID NOT REPORT ANY CONCERNS RELATED TO THE PERFORMANCE OF THE TRUSCULPT SYSTEM, AND NO DEVICE MALFUNCTION WAS IDENTIFIED. A PHOTO OF THE LESION WAS PROVIDED, BUT NO SPECIFIC INFORMATION ABOUT THE TREATMENT SETTINGS OR THE OUTCOME OF THE LESION HAS BEEN RECEIVED. ATTEMPTS BY CUTERA TO OBTAIN ADDITIONAL FOLLOW-UP DETAILS HAVE NOT BEEN SUCCESSFUL. THE TRUSCULPT INSTRUCTIONS FOR USE STATE THAT THE DEVICE SHOULD NOT BE USED TO TREAT THE NECK. THE DECISION TO TREAT THIS AREA WAS MADE BY THE PRACTITIONE

  Patient problems: Localized Skin Lesion; Subcutaneous Nodule

  MAUDE report 22064635 ↗
• InjuryMar 16, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  TREATMENT DATE: (B)(6) 2024. DATE PATIENT REPORTED ADVERSE EVENT TO CLINIC: (B)(6) 2024. DATE INITIAL BURN REPORTED TO CUTERA: (B)(6) 2025. DATE CLINIC PROVIDED CLINICAL INFORMATION ABOUT THE BURN:(B)(6) 2025. EVENT DESCRIPTION: A PATIENT UNDERWENT TREATMENT USING THE TRUSCULPT 16 CM2 HANDPIECE APPLIED TO THE SUBMENTAL AREA AND JAWLINE. FOLLOWING THE PROCEDURE, THE PATIENT DEVELOPED A THIN, LINEAR BURN ON THE UPPER ANTERIOR NECK, IN THE REGION OF THE HYOID BONE, BENEATH THE SUBMENTAL AREA. THE PATIENT DID NOT REPORT THE BURN TO THE CLINIC UNTIL APPROXIMATELY ONE MONTH AFTER TREATMENT. THE BURN SUBSEQUENTLY HEALED WITH A THIN, LINEAR SCAR. IT IS UNKNOWN WHAT TYPE OF WOUND MANAGEMENT, IF ANY, WAS USED DURING THIS PERIOD. PROPER POST-TREATMENT CARE IS ESSENTIAL TO MINIMIZING SCAR FORMATION AND ACHIEVING OPTIMAL COSMETIC OUTCOMES. POTENTIAL CAUSE OF THE BURN: USER ERROR. THE TRUSCULPT DEVICE USES RADIOFREQUENCY (RF) ENERGY TO HEAT SUBCUTANEOUS TISSUE. WHEN THE HANDPIECE IS APPLIED OVER HARD STRUCTURES LIKE THE HYOID BONE, THERE IS AN INCREASED RISK OF THERMAL INJURY. UNLIKE AREAS WITH MORE SOFT TISSUE, BONES DO NOT DISSIPATE HEAT AS EFFECTIVELY, CAUSING HEAT TO CONCENTRATE IN THE THIN

  Patient problems: Partial thickness (Second Degree) Burn; Scar Tissue

  MAUDE report 21615616 ↗
• InjuryOct 5, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE PATIENT (ADULT MALE) EXPERIENCED A DEEP DERMAL BURN IN A CRESCENT SHAPE AT THE CORNER OF THE RF ELECTRODE, WHICH WAS PLACED ON THE PATIENT'S LEFT FLANK AREA (LOWER BACK). THE DEVICE OPERATOR REPORTED THAT THE PATIENT'S PAIN AND PERSPIRATION LEVELS WERE 9 OUT OF 10 DURING THE PROCEDURE. WOUND CARE INVOLVES APPLYING ANTIBIOTIC OINTMENT AND COVERING THE AREA UNTIL FULLY HEALED.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 20379177 ↗
• InjuryOct 1, 2024Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  THIS IS A FOLLOW-UP TO THE INITIAL EMDR FILED ON OCTOBER 1, 2024. AS INITIALLY REPORTED, THE PATIENT RECEIVED A TRUSCULPT ID TREATMENT TO HER ABDOMEN AND FLANKS. THE DEVICE OPERATOR REPORTED THAT WITHIN THE FIRST MINUTE, THE PATIENT COMPLAINED OF A HOT SENSATION ON HER BACK. THE DEVICE OPERATOR STATED THAT SHE PAUSED THE TREATMENT AND CHECKED THE RETURN PADS THAT WERE PLACED ON THE PATIENT'S UPPER BACK AND THEN RESTARTED THE TREATMENT. THE PATIENT APPEARED COMFORTABLE FOR THE REMAINDER OF THE SESSION, WITH NO FURTHER COMPLAINTS. TWO DAYS AFTER THE TREATMENT, THE PATIENT REPORTED A BLISTER TO THE CLINIC. THE CLINIC PROVIDED A PHOTO SHOWING A SMALL, DEEP DERMAL THICKNESS BURN IN THE CENTER OF THE PATIENT'S BACK. THE CLINIC IS PROVIDING WOUND CARE TO THE PATIENT BUT DECLINED TO SPECIFY THE SPECIFIC WOUND CARE BEING PROVIDED FOR THE BURN. AT THE TIME OF THE INITIAL EMDR, CUTERA WAS AWAITING RETURN OF THE RETURN PAD CABLES. THE RETURN PAD CABLES HAVE SINCE BEEN RECEIVED AND TESTED, AND THEY WERE DETERMINED NOT TO HAVE CAUSED OR CONTRIBUTED TO THE EVENT. IN ADDITION, THE ERROR LOG AND RF LOG WERE REVIEWED, AND THERE WERE NO ERRORS NOR PAUSES DURING THE TREATMENT. IT IS UNCLEAR WHY THE DE

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 20349004 ↗
• InjurySep 10, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE PATIENT SUSTAINED A 5 CM X 2 CM PARTIAL THICKNESS BURN AT THE EDGE OF THE HANDPIECES. THE PHOTO OF THE TREATMENT AREA TAKEN IMMEDIATELY AFTER THE PROCEDURE SHOWS THE OUTLINE OF WHERE THE HANDPIECES WERE POSITIONED ON THE LOWER ABDOMEN. THE SKIN IMPRESSIONS INDICATE THAT THE DEVICE OPERATOR POSITIONED THE HANDPIECES TOO CLOSELY IN RELATION TO THE PATIENT'S BMI, CONTRARY TO THE INSTRUCTIONS FOR USE. THE WOUND WAS MANAGED WITH BACTROBAN TOPICAL ANTIBIOTIC.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 20186181 ↗
• InjuryJul 23, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE PATIENT RECEIVED A 2 X 2 CM DEEP PARTIAL THICKNESS BURN BETWEEN TWO HANDPIECES PLACED ON THE LOWER ABDOMEN. THE BURN DEVELOPED INTO A BLISTER AND WAS TREATED WITH POLYSPORIN, VASELINE, AND MEDI-HONEY. THE PATIENT'S REPORTED BMI IS 33.8. THE TRUSCULPT ID INSTRUCTIONS FOR USE STATE THE FOLLOWING: CAUTION: HANDPIECES SHOULD BE SPACED BASED ON THE PATIENT'S BMI AND/OR UNDERLYING FAT THICKNESS IN THE TREATMENT AREA TO PREVENT ADVERSE EVENTS. FOR BMI 26-30 OR >1 CM FAT THICKNESS, PLACE HANDPIECES >1 CM APART. UP TO 2 HANDPIECES CAN BE USED ON LARGE OR SMALL DECALS, VERIFYING 1 CM OR MORE SEPARATION BETWEEN HANDPIECES." THE BURN RESULTED FROM INSUFFICIENT SEPARATION BETWEEN THE HANDPIECES PLACED ON THE LOWER ABDOMEN. SPECIFICALLY, THREE HANDPIECES WERE POSITIONED ON A SINGLE DECAL, LEADING TO INSUFFICIENT SPACE BETWEEN THE HANDPIECES. THE TRUSCULPT ID SYSTEM WAS EVALUATED BY CUTERA FIELD SERVICE AND MET PERFORMANCE SPECIFICATIONS.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 19803092 ↗
• InjuryJul 5, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE 16 CM2 HANDPIECE WAS USED TO TREAT THE SUBMENTUM AND NECK AREA. THE TRUSCULPT ID OPERATOR MANUAL INSTRUCTS THE DEVICE OPERATOR NOT TO TREAT "ON THE HEAD OR ON THE NECK (INCLUDING CAROTID SINUS OR OVER THE TRACHEA OR THYROID CARTILAGE)". THE PATIENT EXPERIENCED A SMALL, LINEAR, DEEP PARTIAL THICKNESS BURN ON THE SIDE OF THE NECK. THE WOUND MANAGEMENT IS BACITRACIN. THE DEVICE IS PENDING INSPECTION AND TESTING BY CUTERA SERVICE.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 19684674 ↗
• InjuryMay 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT RECEIVED A SMALL PARTIAL THICKNESS BURN UNDER THE RETURN PAD. THE PHYSICIAN SENT A PHOTO OF THE BURN, WHICH OCCURRED ON THE PATIENT'S BACK. NO OTHER DETAILS HAVE BEEN PROVIDED. THE PHYSICIAN HAS NOT RESPONDED TO REQUESTS FOR ADDITIONAL INFORMATION ABOUT THE CLINICAL CASE. THERE IS NOT A DEVICE PERFORMANCE COMPLAINT ASSOCIATED WITH THE CLINICAL CASE.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 19326083 ↗
• InjuryMar 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  A DEEP PARTIAL THICKNESS/FULL THICKNESS BURN OCCURRED UNDER THE TRUSCULPT ID HANDPIECE ON THE PATIENT'S LOWER BACK.

  Patient problems: Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn

  MAUDE report 18980978 ↗
• InjuryMar 23, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6), 2024, A PATIENT CONTACTED CUTERA TO REPORT THEY SUFFERED BURNS ON THEIR LOWER RIGHT ABDOMEN DURING A TRUSCULPT ID TREATMENT PERFORMED AT INOVO MEDICAL LOCATED IN GLOUCESTER, ONTARIO, CANADA. THE PATIENT INCLUDED AN UNDATED PHOTO WITH THE INITIAL REPORT THAT SHOWS WHAT APPEARS TO BE A HEALING DEEP PARTIAL THICKNESS BURN (~2 CM X ~1 CM) AND A SUPERFICIAL PARTIAL THICKNESS BURN (~1 CM X ~0.3 CM) ON A STRETCH MARK ON THE PATIENT'S RIGHT LOWER ABDOMEN. CUTERA OPENED A COMPLAINT INVESTIGATION AND HAS REACHED OUT TO THE SITE THE PATIENT REPORTED AS PERFORMING THE TREATMENT. THE SITE STATED THEY ARE UNWILLING TO PROVIDE ANY INFORMATION ABOUT THE TREATMENT OR COOPERATE IN THE INVESTIGATION UNLESS THE PATIENT REPORTS THE BURNS TO THEM AND RETURNS TO BE EXAMINED.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 18965533 ↗
• InjuryMar 18, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A 10 MM X 3 MM CRESCENT-SHAPED DEEP PARTIAL THICKNESS/FULL THICKNESS BURN OCCURRED AT THE TOP RIGHT CORNER OF THE RETURN ELECTRODE PAD ON THE PATIENT'S UPPER BACK. THE ROOT CAUSE WAS DETERMINED TO BE INSUFFICIENT SEPARATION BETWEEN THE RETURN PAD AND THE NEAREST HANDPIECE. THERE IS NOT A DEVICE PERFORMANCE COMPLAINT ASSOCIATED WITH THE EVENT.

  Patient problems: Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn

  MAUDE report 18926256 ↗
• InjuryFeb 22, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A 1 INCH X 0.5 INCH BLISTER DEVELOPED 4 HOURS AFTER TRUSCULPT ID TREATMENT TO THE "TRICEPS". THE BLISTER WAS LOCATED AT THE LOWER EDGE OF THE RETURN PAD ELECTRODE, WHICH WAS PLACED ON THE UPPER BACK. THE WOUND IS CONSISTENT WITH A DEEP PARTIAL THICKNESS/FULL THICKNESS BURN THAT WAS TREATED WITH NON-PRESCRIPTION ANTIBIOTIC OINTMENT (FUCIDIN), 3M SECOND SKIN MOIST BURN PADS, AND 3M HYDROCOLLOID DRESSING. THE ROOT CAUSE WAS DETERMINED TO BE INSUFFICIENT SEPARATION BETWEEN THE RETURN PAD (ON PATIENT'S UPPER RIGHT BACK) AND THE NEAREST HANDPIECE (ON PATIENT'S RIGHT REAR ARM) FOR THE THICKNESS OF SUBCUTANEOUS FAT UNDER THE HANDPIECE. THERE IS NOT A DEVICE PERFORMANCE COMPLAINT ASSOCIATED WITH THE EVENT. THE TRUSCULPT ID SYSTEM WAS EVALUATED BY THE FIELD SERVICE ENGINEER, AND THE DEVICE WAS DETERMINED TO MEET PERFORMANCE SPECIFICATIONS.

  Patient problems: Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn

  MAUDE report 18759775 ↗
• InjuryJan 24, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2023, (B)(6), A PATIENT OF DR. (B)(6), REPORTED IN AN EMAIL WITH PHOTOS AND MEDICAL RECORDS ATTACHED THAT DURING THE 1ST OF 2 THREE-HANDPIECE TRUSCULPT ID TREATMENTS OF POSTERIOR/INFERIOR FAT ON HER UPPER RIGHT AND LEFT ARMS, DELIVERED SEQUENTIALLY ON (B)(6) 2022, SHE TOLD DR. (B)(6) SHE "FELT AN INTENSE BURNING SENSATION" A FEW MINUTES AFTER TREATMENT OF HER RIGHT UPPER ARM BEGAN. (B)(6) REPORT CONTINUED, "DR. (B)(6) PAUSED THE TREATMENT, LOOSENED THE STRAP, AND LOOKED TO SEE IF ANYTHING WAS WRONG" AND THEN "ASKED IF I WAS READY TO CONTINUE. I SAID YES. AFTER THAT THE TREATMENT WAS COMFORTABLE. ONCE THE TREATMENT ON THE RIGHT ARM WAS FINISHED, THE STRAP [CUMMERBUND] AND ELECTRODES [3 HANDSFREE HANDPIECES AND ADHESIVE DECAL] WERE REMOVED. DR. (B)(6) STATED I HAD A TINY [SMALL LINEAR] BLISTER [CLOSE TO THE RIGHT AXILLA] AND INSTRUCTED HER ASSISTANT TO PUT A BAND-AID ON IT. I WAS ASKED BY (B)(6) IF I WAS GOING TO CONTINUE [WITH THE UPPER LEFT ARM TREATMENT, AND] I SAID YES." [THE TREATMENT WAS COMFORTABLE, WELL TOLERATED, AND COMPLETED WITHOUT INCIDENT.] "A FEW HOURS LATER, ONCE I ARRIVED HOME IN THE EVENING, I WENT TO TAKE A SHOWER AND REMOVED THE BAND-AID AND NOTICED THE

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 18577098 ↗
• InjuryDec 22, 2023Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  FULL THICKNESS BURNS ON THE LOWER ABDOMEN FOLLOWING TRUSCULPT ID TREATMENT.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 18387583 ↗
• InjuryJul 1, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON 5/31/2022, A MED SPA CUSTOMER REPORTED THAT DURING A TREATMENT WITH THE TRUSCULPT ID DEVICE FOR BRA FAT REDUCTION USING TWO BOVIE RETURN PADS POSITIONED VERTICALLY JUST BELOW THE SHOULDER BLADES AND FOUR 40 CM2 HANDPIECES, 2 ON THE PATIENT'S LATERAL MIDBACK LEFT AND RIGHT SIDES, RESPECTIVELY, AFTER THE 2 HANDPIECES ON THE PATIENT'S LEFT SIDE HAD CYCLED ONCE WITHOUT ISSUE, THE PATIENT REPORTED SIGNIFICANT HEAT/PAIN ON THE RIGHT SIDE ABOUT 1 MINUTE INTO THE RIGHT-SIDE HANDPIECES' HEATING CYCLE (WHEN THE HANDPIECE TEMPERATURES HAD REACHED 43C). THE TREATMENT WAS PAUSED WHILE RIGHT-SIDE HANDPIECES WERE "RE-ADJUSTED." THE TREATMENT WAS BRIEFLY RESUMED, WITH THE PATIENT AGAIN REPORTING SIGNIFICANT HEAT/PAIN, BEFORE BEING ABORTED. WHEN THE RIGHT SIDE BOVIE RETURN PAD WAS BEING REMOVED, A SMALL AREA OF THE PATIENT'S SKIN AT THE CORNER OF THE RETURN PAD CLOSEST TO THE IMMEDIATELY ADJACENT HANDPIECE "LIFTED AND PULLED AWAY WITH THE BOVIE [RETURN] PAD." THE PROVIDER "PUT BANDAGES OVER IT [THE TORN SKIN] AND TOLD HER TO KEEP US UPDATED". THE FOLLOWING DAY, THE PATIENT TEXT IMAGES OF THE "TORN SKIN" TO THE TREATMENT PROVIDER SHOWING A CRESCENT-SHAPED SMALL (3 MM WIDE X 10 MM LONG) FULL THICK

  Patient problems: Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn; Skin Infection

  MAUDE report 14895646 ↗
• InjuryJun 7, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  FULL AND PARTIAL THICKNESS BURNS AT CONNECTION POINT BETWEEN THE RETURN CABLE AND BOVIE NEUTRAL ELECTRODE.

  Patient problems: Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn

  MAUDE report 14628450 ↗