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Model Number 1500-004-30
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Full thickness (Third Degree) Burn (2696)
Event Date 02/20/2018
Event Type  Injury  
Manufacturer Narrative
On 2/20/18 (b)(6) received an email from (b)(6), pdp from customer stating during (b)(6) visit to the practice on (b)(6) 2018 both had reportedly experienced 3rd degree burns after undergoing diva external treatments.(b)(6) contacted (b)(6) for further clarification and contacted the customer.(b)(6) and (b)(6) are two of the staff members that underwent external diva treatments on (b)(6) 2018.I discussed their current state as well as medical attention/prescriptions given.Both (b)(6) and (b)(6) have not yet received medical attention as of our conversation.I advised (b)(6) and (b)(6) to send me the settings used and any products currently applying to the area.(b)(6) and (b)(6) did not inform their medical director dr.(b)(6) of this event and stated they would speak with him in the morning of 2/21/18.(b)(6) made a dr.'s appointment but cancelled because she got her period.(b)(6) said she was using over the counter products recommended by her pharmacist and that she would be going to her gyn this evening.The diagnosis of 3rd degree burns were from (b)(6), aesthetician who states "i know what a 3rd degree burn is".Both patients state they have been uncomfortable since their treatment and didn't report anything because they thought it was a "normal" feeling.On 2/20/18 spoke with (b)(6) and (b)(6) via conference call.Asked for both to email me their settings and events that lead up to this incident.I urged both to seek medical attention by their physician at least to avoid possible infection, etc.I advised (b)(6) and (b)(6) to contact me on 2/21/18 to give me their status and the recommendation of their md consult.I advised they speak w/dr.(b)(6) and explain the events that occurred on (b)(6)18 that resulted in this incident.Email with pictures and settings were emailed to me and shared with (b)(6), rn.Photo's were fuzzy and no eschar appeared to be present.Will await recommendation from physician consult.On 2/21/18 received a phone call from dr.(b)(6) at 3pm (eastern) who was very upset and was unaware of the events on (b)(6) 2018 that resulted in this incident.I asked if their staff had received medical attention and he said only (b)(6) had and that he has only seen pictures and spoken with (b)(6) and (b)(6) but did not look at the treated areas.(b)(6) contacted (b)(6) and it was determined that we get a kol involved to offer some medical advice.(b)(6), md was emailed treatment information for both (b)(6) and (b)(6).Photos, medications, and medical history for (b)(6) was emailed to dr.(b)(6) as well.As of 10pm on 2/21/18 no photographs or medical history including medications have been received for (b)(6).Dr.(b)(6) to call dr.(b)(6) on 2/22/18 at 8:45am cst to discuss.(b)(6) text (b)(6) to send a detailed event of her day in dr.(b)(6) office on (b)(6) 2018.(b)(6) advised (b)(6) to call her on 2/22/18 to let me know how she and (b)(6) are doing.Spoke w/ dr.(b)(6), confirming he spoke with dr.(b)(6) and gave wound care advice consisting of vaseline to affected areas and keeping the treated areas clean.Repeatedly reached out for clarification on who performed the external treatments and have received no response to my requests.(b)(6) e-mail dated 2/25/2018 to (b)(6) stated that "during the treatments (b)(6) asked me to be in the room.At no time did i operate the laser.I watched as (b)(6) and (b)(6) treated one another.Knowing that they had been through our sciton clinical in-service training it was my understanding that they knew what to do." (b)(4) spoke with dr.(b)(6) on 5/1/2018 and asked to inquire about the two patients, (b)(6) and (b)(6).He said he will send the documentation to allow me to close the adverse event file.(b)(4) called on 5/7/2018 to inquire about the promised documentation.(b)(6) at dr.(b)(6) office took the message and said that she will contact dr.(b)(6) and remind him of the request.Dr.(b)(6) called and left a message to call back.(b)(4) spoke with dr.(b)(6) on 5/8/2018.He claimed that the patients were "burned by the trainer" and that the patents are experiencing "continued pain, redness and discharge" but he said he was not their treating physician.He also said that he is very disappointed with how sciton has "not been responsive to the girls." he said he had not heard from (b)(4) and (b)(4) has not offered any meaningful solution.(b)(4) called (b)(6) on 5/9/2018 advising her of the conversation with dr.(b)(6).She indicated that she had tried to contact (b)(6) previously but had not heard from her.(b)(4) suggested that she, as well as (b)(6), call (b)(6) and (b)(6) to learn more.(b)(6) called (b)(6) on her personal cell phone on 5/9/2018 and left her a message to return her call.Since (b)(6) had not heard from (b)(6), she again called (twice) on 5/18/2018 and ended up leaving messages to return her calls.(b)(6) tried contacting (b)(6) during the week of 5/21/2018 but was not successful in connecting with (b)(6) regarding status of this reported adverse event.
Event Description
Two patients reportedly experienced 3rd degree burns after undergoing diva external treatments.
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Brand Name
Type of Device
Manufacturer (Section D)
925 commercial street
palo alto CA 94303
Manufacturer (Section G)
925 commercial street
palo alto CA 94303
Manufacturer Contact
jay patel
925 commercial street
palo alto, CA 94303
MDR Report Key7551223
MDR Text Key109497799
Report Number2953696-2018-00022
Device Sequence Number1
Product Code GEX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Health Professional
Type of Report Initial
Report Date 05/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2018
Is this an Adverse Event Report? Yes
Device Operator Health Professional
Device Model Number1500-004-30
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/20/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/08/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;