MAUDE Adverse Event Report: COSMAN MEDICAL RF CANNULA

Model Number	RF-C101020S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Skin Irritation (2076)
Date of Event	07/28/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
A report was received that a patient experienced an infection in their back at the cannula site following the procedure.The patient's low back was red.A dermatologist determined that the patient had folliculitis.The patient was prescribed antibiotics which resolved the infection in a few days.

• Brand Name: RF CANNULA
• Common Device Name: CANNULA
• Manufacturer (Section D): COSMAN MEDICAL; 22 terry ave; burlington MA 01803
• MDR Report Key: 6801410
• Report Number: 3006630150-2017-02983
• Device Sequence Number: 1115749
• Product Code: GXI
• UDI-Device Identifier: 00813250012040
• UDI-Public: 00813250012040
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K060799
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 07/28/2017

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: Physician
• Device Model Number: RF-C101020S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2017
• Initial Report FDA Received Date: 08/17/2017
• 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: Required Intervention