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	12/10/2021
Type of Reportable Event	Serious Injury
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.Log files investigation form the day of the event revealed 6 abnormal pulses with error messages #112 and 3 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.While the patient used alastin nectre (collagen and elastin cream) and received few combination treatments of prp, micro-needling and dysport to reduce the possibility of there being a residual appearance from the burns, 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.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.
Event or Problem Description
A patient developed 2 burns during sofwave treatment.The site reported that prior to the event occurrence an error message #112 appeared on the screen several times.Error message #112 is to notify the operator "please verify good contact with skin.If the problem persists, please contact sofwave support".One week following the event both burns were improved.The patient used alastin nectre (collagen and elastin cream) and received a few combination treatments of prp, micro-needling and dysport.We believe it is unclear whether these cosmetic procedures 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.About two weeks after significant improvement was observed.

• Brand Name: SOFWAVE
• Common Device Name: SOFWAVE
• Manufacturer (Section D): SOFWAVE MEDICAL LTD; hatotsma 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: 13620659
• Report Number: 3015889734-2021-60001
• Device Sequence Number: 4369266
• Product Code: OHV
• UDI-Device Identifier: 07290018152003
• UDI-Public: (01)07290018152003(21)
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2021

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
• Operator of Device: Health Professional
• Device Model Number: SOFWAVE
• Device Catalogue Number: FG00001
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2021
• Initial Report FDA Received Date: 02/28/2022
• 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: ALASTIN NECTRE CREAM; PRP, MICRONEEDLING & DYSPORT TREATMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female