MAUDE Adverse Event Report: COSMAN MEDICAL CANNULA 10CM 10MM TIP 18G SHARP CURVED; PROBE, RADIOFREQUENCY LESION

Model Number	RFK-C101018S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	05/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device components involved: model #: rfk-c101018s, lot #: m607, description: rfk cannula, 10cm; 10mm active tip, sharp, curved,18g quantity: 4, model #: csk-10, lot #: f138, description: csk-10 kit includes: 1ea.Csk 100mm tc electrode, 1ea.Cb112-tc cable, 1ea.Sterilizing case quantity: 2 model #: csk-10 lot #: i243 description: csk-10 kit includes: 1ea.Csk 100mm tc electrode, 1ea.Cb112-tc cable, 1ea.Sterilizing case quantity: 1 model #: csk-10 lot #: l535 description: csk-10 kit includes: 1ea.Csk 100mm tc electrode, 1ea.Cb112-tc cable, 1ea.Sterilizing case quantity: 1 it is indicated that the devices will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.A review of the device history records will be conducted.If there is any further relevant information from that review, a supplemental med watch will be filed.
Event or Problem Description
A report was received that one week following an rf ablation procedure, a patient experienced 8 skin tags on his back at the insertion site of the needles.The physician assessed that the patient experienced an allergic reaction, it is unknown if treatment was provided for the symptoms.An allergy test was performed but the results will not be provided.The patient's status is stable.

• Brand Name: CANNULA 10CM 10MM TIP 18G SHARP CURVED
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): COSMAN MEDICAL; 22 terry ave; burlington MA 01803
• MDR Report Key: 7549404
• Report Number: 3006630150-2018-01884
• Device Sequence Number: 1775941
• Product Code: GXI
• UDI-Device Identifier: 00813250012101
• UDI-Public: 00813250012101
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/29/2018

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: 10/13/2021
• Device Model Number: RFK-C101018S
• Device Lot Number: M607
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2018
• Initial Report FDA Received Date: 05/29/2018
• 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