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

Model Number	CC101020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	07/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was discarded and will not be returned.It is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the manufacturing documentation of the device found that no anomalies or deviations potentially related to the event occurred during manufacturing.A review of the sterilization records of the device found them to be satisfactory.
Event or Problem Description
A report was received that two weeks after a radiofrequency procedure the patient experienced a reaction that were initially assessed to be burn marks at the puncture site.The sizes of the marks were less than 1 centimeter and were located at l3-s1.During the procedure it was noted that the physician injected 1-2 ml of trigon 400 mg/ml with saline through the cannulas.They did not use any skin preparation or dressing that could have gotten into 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 believe it could be an allergic reaction.The patient was administered a two month prescription for corticoid ointment the patient is doing fine.There is no further course of action.

• Brand Name: RF CANNULA
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): COSMAN MEDICAL; 22 terry ave; burlington MA 01803
• MDR Report Key: 7499015
• Report Number: 3006630150-2018-01628
• Device Sequence Number: 1718486
• Product Code: GXI
• UDI-Device Identifier: 00813250012712
• UDI-Public: 00813250012712
• 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
• 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 Expiration Date: 02/20/2021
• Device Model Number: CC101020
• Device Lot Number: I986
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2017
• Initial Report FDA Received Date: 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