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

Model Number	RFK-C101020VZ-P
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
Event date: (b)(6) 2018 additional suspect medical device components involved: model: rfk-c101020sz-p, lot #: j256, description: rfk cannula, siliconized, 100mm, 10mm tip, 20g, sharp, curved 10/pk.The devices were not returned to bsn as they were discarded by the medical facility.A review of the manufacturing documentation for the devices revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.
Event or Problem Description
A report was received that a patient developed temporary weals at the cannula insertion sites a week after the procedure.The patient's skin was itchy.The physician says it appears to be type 4 (delayed skin immune cell mediated) hypersensitivity response.It is unknown if any medical intervention was performed.The physician prepped the patient's skin with chloraprep.The physician is unsure, but believes it is possible that chloraprep could be the cause or the cause could be the cannulas.

• Brand Name: RFK CANNULA
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): COSMAN MEDICAL; 22 terry ave; burlington MA 01803
• MDR Report Key: 7403348
• Report Number: 3006630150-2018-01267
• Device Sequence Number: 19028870
• Product Code: GXI
• UDI-Device Identifier: 00813250016895
• UDI-Public: 00813250016895
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K060799
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/06/2018

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: 06/19/2021
• Device Model Number: RFK-C101020VZ-P
• Device Lot Number: L359
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2018
• Initial Report FDA Received Date: 04/06/2018
• 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