MAUDE Adverse Event Report: VENUS CONCEPT LTD. VENUS VERSA SYSTEM

Model Number	COMMON MODEL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage, Subdural (1894)
Date of Event	11/09/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018 the patient had 3rd treatment with venus versa system using diamond polar applicator, on her face.The initial diagnosis of the patients that evening was stroke.The final diagnosis is genetic blood disorder.According to md, the incident most likely happened because of her previous medical history.Post investigation, according to the md, the patient did not suffer from stroke and no lateral injuries(as was initially perceived).It was discovered that patient has a genetic blood condition that makes her blood too thick , the incident accordingly most likely happened because of her previous medical history (thrombophlebitis,was prescribed anticoagulant, and later she discontinue anticoagulants; reason for which is unknown).The patient suffered prolong thrombophlebitis in the past and had related surgery on her leg veins 3 months before the treatment.Patient suffered overweight, 75 lb above the average.The patient was initially hospitalized and could not speak, and then her condition improved and she returned home.The clinic knew that the patient used to take anticoagulants medications.Venus versa system treatment parameters: total treatment duration: 30 min: 20 min with the following parameters: rf = 35% = 26.25w; pemf = 100% = 15gauss, rf = 1 mhz, mp = 15 hz, followed by a 10 min treatment with the following parameters: rf = 3 0% = 22.5w; pemf = 100% = 15gauss, rf = 1 mhz, mp = 15 hz.Related system accessory passed service test post event to ensure device appropriate functionality.Several attempts were performed to get further information on patient condition.No reply was received to this date.

• Brand Name: VENUS VERSA SYSTEM
• Common Device Name: VENUS VERSA SYSTEM
• Manufacturer (Section D): VENUS CONCEPT LTD.; hayozma street, bld. 6; yokne'am, 20692 03; IS 2069203
• MDR Report Key: 8872760
• Report Number: 3008915316-2018-00001
• Device Sequence Number: 14067721
• Product Code: ONF
• UDI-Device Identifier: 07290016540383
• UDI-Public: 07290016540383
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K153717
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 11/14/2018
• 2 Devices were Involved in the Event: 1 2

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: COMMON MODEL
• Device Catalogue Number: VE102407
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 08/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 50 YR