MAUDE Adverse Event Report: COSMAN MEDICAL RF CANNULA; 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	02/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Expiration date: ni.The device was discarded and will not be returned.
Event or Problem Description
A report was received that after a radiofrequency procedure the patient noticed that he had six skin tags on his back.It was noted that each tag corresponded to each needle incision, three per side, so the physician associated the event with the cannula.The tags were red, round shaped, and less than 2 cm.During the procedure it was noted that the physician injected saline through the cannulas.They did not use any skin preparation or dressing that could have gotten into the puncture site.The physician does not know the cause of the reaction but believe it could be an allergic reaction.The patient was administered prescription corticoid medication.The patient is stable.
Additional Manufacturer Narrative
Additional information was received that the results of the allergy test will not be provided.
Event or Problem Description
A report was received that after a radiofrequency procedure the patient noticed that he had six skin tags on his back.It was noted that each tag corresponded to each needle incision, three per side, so the physician associated the event with the cannula.The tags were red, round shaped, and less than 2 cm.During the procedure it was noted that the physician injected saline through the cannulas.They did not use any skin preparation or dressing that could have gotten into the puncture site.The physician does not know the cause of the reaction but believe it could be an allergic reaction.The patient was administered prescription corticoid medication.The patient is stable.

• Brand Name: RF CANNULA
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): COSMAN MEDICAL; 22 terry ave; burlington MA 01803
• MDR Report Key: 7393829
• Report Number: 3006630150-2018-01247
• Device Sequence Number: 1092156
• 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,Followup
• Report Date (Section B): 05/10/2018

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-C101018S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/13/2018
• Supplement Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 04/03/2018
• Supplement Report FDA Received Date: 05/10/2018
• 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