MAUDE Adverse Event Report: COSMAN MEDICAL RF CANNULA; PROBE, RADIOFREQUENCY LESION

Model Number	RFK-C101020S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The cannula was not returned to bsn as it was discarded by the medical facility.
Event or Problem Description
A report was received that after a radiofrequency procedure the patient experienced a reaction that was initially assessed to be burn marks at the puncture site.The physician felt that marks were related to use of the cannula, and later assessed that he doesn't know the cause of the reaction but believes it could be an allergic reaction.The patient was administered a prescription for corticoid and the patient is doing fine.
Additional Manufacturer Narrative
Additional information was received that the sales representative was aware of the patients allergic reaction on (b)(6) 2017.
Event or Problem Description
A report was received that after a radiofrequency procedure the patient experienced a reaction that was initially assessed to be burn marks at the puncture site.The physician felt that marks were related to use of the cannula, and later assessed that he doesn't know the cause of the reaction but believes it could be an allergic reaction.The patient was administered a prescription for corticoid and the patient is doing fine.
Additional Manufacturer Narrative
Further investigation revealed that the rfk cannulas are composed of 304 stainless steel hypo tubing which contains both chromium and nickel.
Event or Problem Description
A report was received that after a radiofrequency procedure the patient experienced a reaction that was initially assessed to be burn marks at the puncture site.The physician felt that marks were related to use of the cannula, and later assessed that he doesn't know the cause of the reaction but believes it could be an allergic reaction.The patient was administered a prescription for corticoid and the patient is doing fine.

• Brand Name: RF CANNULA
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): COSMAN MEDICAL; 22 terry ave; burlington MA 01803
• MDR Report Key: 7336176
• Report Number: 3006630150-2018-01004
• Device Sequence Number: 16162914
• Product Code: GXI
• UDI-Device Identifier: 00813250012040
• UDI-Public: 00813250012040
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K060799
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/09/2018

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: RFK-C101020S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/13/2018
• Supplement Date Received by Manufacturer: 03/14/2018; 04/18/2018
• Initial Report FDA Received Date: 03/13/2018
• Supplement Report FDA Received Date: 04/10/2018; 05/09/2018
• 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