MAUDE Adverse Event Report: SOFWAVE SOFWAVE

Model Number	SOFWAVE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	04/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Subject (skin type iii-iv) underwent sofwave treatment on (b)(6) 2022 on face, neck and submental.Pronox/topical blt was used as pre-treatment sedation.As well, subject also took some type of medical marijuana at home.Patient had botox 2 weeks prior to the treatment (on the forehead, glabella and crow's feet).Treatment parameters were 4.8-5.0j, 172 pulses were applied with 1 second post-cooling in continuous mode (1 second interval).Treatment included single pass on forehead, 3 passes on cheeks and 2 passes on neck.Welts with the applicator footprint were observed on the patient's chin area immediately after treatment in the clinic.One day after ((b)(6) 2022), the patient called the clinic to notify of the applicator marks.Two days after ((b)(6) 2022) subject was seen by the clinic doctor and he reported that burns were developed with the applicator footprint.
Additional Manufacturer Narrative
The investigation involved direct communication with the physician in the clinical site as well as the analysis of the log files from the device and the investigation of the device applicator.Investigation revealed that 172 pulses were applied with energy 4.6-5.0j, of those 3 abnormal pulses with error messages #112 and 7 abnormal pulses with error messages #117 ("please verify good contact with skin.If the problem persists, please contact sofwave support").The system control mechanism behaved as expected in all abnormal pulses and no malfunction was detected.The patient used occlusive ointment/silvadene cream, otc steroid cream and minocycline oral.Hydroquinone and westcort topical were also prescribed.Patient underwent a micro needling procedure at the beginning of july to fully resolve the burn.It is unclear whether these cosmetic procedures would be considered medical intervention to preclude permanent impairment or permanent damage.Nonetheless, out of an abundance of caution we are reporting this event.

• Brand Name: SOFWAVE
• Common Device Name: SOFWAVE
• Manufacturer (Section D): SOFWAVE; haotsma 1; yokneam ilit, israel 20692 ; IS 20692
• Manufacturer (Section G): SOFWAVE MEDICAL LTD; hatosma 1; yokneam ilit, israel 20692 ; IS 20692
• Manufacturer Contact: shlomit mann ; hatosma 1; yokneam ilit, israel 20692 ; IS 20692
• MDR Report Key: 15014418
• Report Number: 3015889734-2022-00043
• Device Sequence Number: 11392271
• Product Code: OHV
• UDI-Device Identifier: 07290018152003
• UDI-Public: (01)07290018152003(21)
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K211483
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/01/2022

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
• Operator of Device: Health Professional
• Device Model Number: SOFWAVE
• Device Catalogue Number: FG00001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2022
• Initial Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2021
• 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: HYDROQUINONE; MICRO NEEDLING; MINOCYCLINE; OCCLUSIVE OINTMENT/SILVADENE CREAM; OTC STEROID CREAM; WESTCORT TOPICAL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female