MAUDE Adverse Event Report: CIRCULARITY HEALTHCARE LLC D'OXYVA - CIRCULARITY HEALTHCARE CO2 TREATMENT; PROTECTOR, SKIN PRESSURE

Medical Device Problem Codes	Nonstandard Device (1420); Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
D'oxyva - circularity healthcare co2 treatment, co2 device, non-invasive transdermal delivery system.(b)(6) their company claims its products are life saving and regenerative, even in grave health crisis.The wand cartridges, which contain contents under pressure, are highly volatile and promote risk of injury.At least one aspect of their initial wand was recalled and replaced, due to defect.They continue to financially exploit unsuspecting, desperately ill and dying patients with their ongoing scam.This company continues to financially abuse and physically injure consumers.Fda safety report id# (b)(4).

• Brand Name: D'OXYVA - CIRCULARITY HEALTHCARE CO2 TREATMENT
• Common Device Name: PROTECTOR, SKIN PRESSURE
• Manufacturer (Section D): CIRCULARITY HEALTHCARE LLC ; 790 east colorado boulevard; floor 9; pasadena CA 91101
• MDR Report Key: 12615575
• Report Number: MW5104515
• Device Sequence Number: 10354077
• Product Code: FMP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/08/2021
• Patient Sequence Number: 1