MAUDE Adverse Event Report: SOFWAVE MEDICAL LTD 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	01/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, a patient underwent sofwave treatment and developed tiny burns in the corner of her nose, lip and chin.No error messages were reported by the provider during the treatment.There were no special events or error messages displayed to the user.The applied energy for all pulses delivered during the treatment was within the device specifications.Prior to treatment, topical anesthetic cream composed of 23% lidocaine and 7% tetracaine was applied for 45 minutes.On (b)(6) 2022 the patient condition was improved.On (b)(6) 2022: the patient condition continued to improve significantly, and filler was injected to the chin into the affected area to accelerate recovery (3 weeks following sofwave treatment).One day following, the event completely resolved ((b)(6) 2022).We believe it is unclear whether this cosmetic procedure would be considered medical intervention to preclude permanent impairment or permanent damage, but we are, nonetheless, reporting this event out of an abundance of caution.
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.No abnormality was found in the log files investigation.The device performed as expected.No malfunction was found.Filler was injected to the chin into the affected area to accelerate recovery (3 weeks following sofwave treatment) to reduce the possibility of there being a residual appearance from the burns, it is unclear whether this cosmetic procedure would be considered medical intervention to preclude permanent impairment or permanent damage.Nonetheless, out of an abundance of caution we are reporting this event.The delay in submission was because of issues in registration and activation of the webtrader.We worked with fda to resolve issues with their data in the establishment registration database that was preventing account activation.
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.No abnormality was found in the log files investigation.The device performed as expected.No malfunction was found.Filler was injected to the chin into the affected area to accelerate recovery (3 weeks following sofwave treatment) to reduce the possibility of there being a residual appearance from the burns, it is unclear whether this cosmetic procedure would be considered medical intervention to preclude permanent impairment or permanent damage.Nonetheless, out of an abundance of caution we are reporting this event.
Event or Problem Description
On (b)(6) 2022, a patient underwent sofwave treatment and developed tiny burns in the corner of her nose, lip and chin.No error messages were reported by the provider during the treatment.There were no special events or error messages displayed to the user.The applied energy for all pulses delivered during the treatment was within the device specifications.Prior to treatment, topical anesthetic cream composed of 23% lidocaine and 7% tetracaine was applied for 45 minutes.On (b)(6) 2022 the patient condition was improved.On (b)(6) 2022: the patient condition continued to improve significantly, and filler was injected to the chin into the affected area to accelerate recovery (3 weeks following sofwave treatment).One day following, the event completely resolved ((b)(6) 2022).We believe it is unclear whether this cosmetic procedure would be considered medical intervention to preclude permanent impairment or permanent damage, but we are, nonetheless, reporting this event out of an abundance of caution.

• Brand Name: SOFWAVE
• Common Device Name: SOFWAVE
• Manufacturer (Section D): SOFWAVE MEDICAL LTD; hatosma 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: 13620948
• Report Number: 3015889734-2022-10001
• Device Sequence Number: 4555783
• Product Code: OHV
• UDI-Device Identifier: 07290018152003
• UDI-Public: (01)07290018152003(21)
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K211483
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/25/2022

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2021
• 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: FILLER WAS INJECTED TO THE CHIN 3 WEEKS AFTER TX.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female