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| Model Number TRUSCULPT ID |
| Device Problem
Improper or Incorrect Procedure or Method (2017)
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| Patient Problem
Full thickness (Third Degree) Burn (2696)
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| Event Date 08/03/2022 |
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Event Type
Injury
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Event Description
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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 big burn on my arm, so i immediately call[ed] dr.(b)(6) office leaving a message.The following day (b)(6) i received a call (b)(6) patient coordinator] asking to send over photos that she could share with (b)(6)." the photos were sent, and the office called in a 7-day prescription for keflex 500 mg.The following day, rx silvadene was added, an (b)(6) 2022 follow-up appointment was scheduled during which dr.(b)(6) scheduled an appointment for (b)(6) to be seen by dr.(b)(6) at a burn clinic on (b)(6) 2022, and on (b)(6) 2022 a 10-day prescription refill for keflex 500 mg was called in.(b)(6) visited dr.(b)(6) on (b)(6) 2022 where the wound was diagnosed as a "1% full thickness contact burn to r axilla".She was instructed to "apply gentamicin and collagenous, keep wound covered" and "return to clinic in 2 weeks." since (b)(6) was no longer returning calls from dr.(b)(6) office, after her visit with dr.(b)(6) on (b)(6) 2022, she was deemed lost to follow-up by dr.(b)(6).(b)(6) attended the follow-up visit with dr.(b)(6) on (b)(6) 2022.No healing of the wound was seen, so it was decided to perform an excision and primary closure of the non-healing wound.The excision and primary closure procedure was performed by dr.(b)(6) on (b)(6)2022, and (b)(6) was seen in a follow-up appointment eight days later (b)(6) 2022 where she was "recovering appropriately" and instructed "can leave wound open wash daily no scrubbing" with "no activity restrictions from burn surgery standpoint".
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Manufacturer Narrative
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In the 16 months since the incident occurred, the device has been used by the customer numerous times, all without reports of adverse events occurring.Unfortunately, due to memory space limitations, the rf treatment data recorded by the device for all treatments would have been overwritten many times from this continued use.This includes data from the treatment during which the incident occurred, and the subsequent treatment of patient's left upper arm which was comfortably tolerated.Since no information could be recovered from the device for analysis, a request to have the device returned to the manufacturer for inspection was not made.The patient's and physician's accounts of the incident have significant differences but are consistent in stating that at the start of the treatment of the patient's right arm, her arm was at her side rather than raised and away from her body as her left arm was for the full duration of the 2nd treatment.It is important to note that physically fitting three 40 cm2 handpieces, each 7.2 cm across (including the 0.4 cm plastic housing on each side of the electrode), with the required 0.5 to 1.0 cm separation them, between the elbow and axilla of a 5'4" bmi 27 female patient without having a handpiece edge very close to or within the axilla would be difficult at best, especially if the patient's arm is at her side.Note also, the thickness of subcutaneous fat within and close to the axilla is far thinner than that on a patient's posterior/inferior upper arm.Rf current, when within skin, will find the path of least resistance (least combined fat thickness and travel distance through skin) to the neutral return pad and the energy delivered to tissue is proportional to the product of current density squared and tissue resistance, meaning tissues along the path of least resistance will be heated more than tissues along paths of higher resistance.It's likely the burn occurred when the patient reported feeling "an intense burning sensation" several minutes into the treatment (when her arm was at her side) and that when the treatment was paused, the cummerbund unwrapped, the skin inspected (prior to the burn becoming visible as a blister), then rewrapped, her arm was positioned further from her side increasing the distance from the edge of the handpiece to her right axilla and increasing the impedance of that path to the neutral return pad, since, when resumed, the treatment remained comfortable until its completion.For the treatment of the patient's left upper arm, her arm was raised when the treatment began so the handpiece was sufficiently far from the axilla making the path of least resistance through the skin and fat directly under the handpiece and the full treatment comfortable.Blisters from deep partial thickness burns take time to develop; so, the physician's account of the blister being small and linear when noticed after the patient's right arm treatment had been completed and instructing her assistant to cover it with a band-aid, is consistent with the "big burn" (blister) the patient reported when she called the physician's office a few hour after the treatment when she removed the band-aid prior to a shower that night.The physician correctly put the patient on oral antibiotics within 24 hours and rx silvadene 24 hours later when the burn worsened.The physician's report includes surprise that "small burn" seen continued to worsen which they associated with the patient being a smoker and having mct disease, hashimoto thyroiditis, and asthma as preexisting conditions.In conclusion, a definitive root cause for the burn could not be determined due to the delay in receiving the initial report of the incident and to conflicting information in the accounts of the incident given by the patient and physician, and within the physician's medical records for the treatment; however, it is our opinion that unintended use error (hp1 too close to or partially with the patient's right axilla when the patient's arm was at her side for the first third of the treatment) was the primary cause of the 1% full thickness burn to the patient's right axilla, and that the patient being a smoker and having mct disease and hashimoto thyroiditis as preexisting conditions delayed or prevented the burn from healing when treated correctly by the physician.
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