MAUDE Adverse Event Report: SYNERON MEDICAL, LTD PROFOUND SYSTEM; ELECTROSURGICAL UNIT AND ACCESSORIES

Model Number	FG70514
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	06/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Candela service engineer evaluated and tested the device and found device meets candela specifications.Candela quality and clinical teams reviewed the initial reported event and based on timelines and documentation provided by the customer; it was determined that the patient was within the anticipated healing timeframe post treatment with the profound system.Treatment with the dermal applicator applied to the lower face and neck would not affect the brow; it was also reported patient had botox prior to the reported brow asymmetry.There have been no prior reported cases of persistent or permanent 'facial nerve damage' of this type and determined not reportable.Customer has been using the profound system since 2017 with no prior reported adverse events.Provider was trained by candela.Additional training was offered and declined as customer administrator felt there was good confidence with using device.Request for additional information related to event was requested (i.E., before and after photographs) and has not been provided.Upon receipt of new information, citing proof of "facial nerve (nerve vii) damage," candela quality and clinical teams reviewed all available details provided by the customer, and note that reported symptoms of this nature appearing 'one week' post treatment is atypical given the anticipated healing sequence and therefore likely not related to the profound device.This is the first known report of alleged permanent nerve damage reported to candela.A supplemental mdr will be submitted upon receipt of new and/or relevant information.(b)(4).
Event or Problem Description
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 information from customer by email stating, "we have enough documents and photos to prove facial nerve (nerve vii) damage with this instrument." additional information solicited.

• Brand Name: PROFOUND SYSTEM
• Common Device Name: ELECTROSURGICAL UNIT AND ACCESSORIES
• Manufacturer (Section D): SYNERON MEDICAL, LTD; industrial zone po box 550; yokneam, 20692 0; IS 206920
• Manufacturer (Section G): SYNERON MEDICAL LTD; industrial zone po box 550; yokneam, 20692 0; IS 206920
• Manufacturer Contact: greg wallender ; 251 locke drive; marlborough, MA 01752
• MDR Report Key: 12972122
• Report Number: 3003772750-2021-00004
• Device Sequence Number: 19937386
• Product Code: PBX
• UDI-Device Identifier: 07290109952444
• UDI-Public: (01)07290109952444
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K161043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: FG70514
• Device Catalogue Number: FG70514
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 12/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BOTOX
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Female