MAUDE Adverse Event Report: ORTHO8 INC. CIRCUL8 PRO; DVT PREVENTION DEVICE

Model Number	08-0027
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	01/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Hematoma formed on the right leg under the compression sleeve.The attending physician had to drain the hematoma and change the patient's anticoagulant medication.
Additional Manufacturer Narrative
Did not find anything wrong with units, appear to operate as designed.The following were completed: one dc barrel jack showed some signs of bending, did confirm barrel jack still working ok.Visual review of both units did not show any signs of marks or damage to both units and wraps.Visual inspection - inside wraps show no marks or damage and smooth, no extraneous objects both units powered up with green status led and pump cycle appears normal.3 full pump cycles appear ok on both units, units tested by wrapping "wrap" back on itself.Both units appear to charge battery when dc charger is plugged in.

• Brand Name: CIRCUL8 PRO
• Common Device Name: DVT PREVENTION DEVICE
• Manufacturer (Section D): ORTHO8 INC.; 2217 plaza drive; rocklin CA 95765
• Manufacturer (Section G): ORTHO8 INC.; 2217 plaza drive; rocklin CA 95765
• Manufacturer Contact: john beasley ; 2217 plaza drive; rocklin, CA 95765
• MDR Report Key: 13865375
• Report Number: 3014676071-2022-00001
• Device Sequence Number: 19277375
• Product Code: JOW
• UDI-Device Identifier: 00194832000021
• UDI-Public: (01)00194832000021(10)CP0821072001
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K212731
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/17/2022

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: Lay User/Patient
• Device Model Number: 08-0027
• Device Lot Number: CP0821072001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female