MAUDE Adverse Event Report: COSMAN MEDICAL RFK-C101020S; RADIOFREQUECNY CANNULA

Model Number	RFK
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/27/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, we are unable to provide any additional information as the product is not returned to cosman for an evaluation.We are continuing to pursue the return of the product for thorough investigation.Inspection of the in-house inventory from the same lot show that products were manufactured correctly.
Event or Problem Description
The facility reported that the patient exhibited one burn on her back following few days after the ablation.The location was on her lower back and that she is a smaller patient.The location of the patch was on her calf.
Additional Manufacturer Narrative
Cosman medical engineering team performed an evaluation on existing inventory on (b)(4) from the lot g301.There was no non-conformance.Cosman team evaluated the box with six remaining cannulas that the facility sent for an evaluation; suspect needles were not available.
Event or Problem Description
The facility reported that the patient exhibited burn on her back following few days after the ablation.The location was on her back.According to the physician assistant, the patient is currently doing well.

• Brand Name: RFK-C101020S
• Common Device Name: RADIOFREQUECNY CANNULA
• Manufacturer (Section D): COSMAN MEDICAL; 22 terry ave; burlington MA 01803
• MDR Report Key: 6095391
• Report Number: 3004867882-2016-00002
• Device Sequence Number: 16234061
• Product Code: GXI
• UDI-Device Identifier: 00813250010756
• UDI-Public: 813250010756
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K060799
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2016

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: 04/04/2020
• Device Model Number: RFK
• Device Catalogue Number: RFK-C101020S
• Device Lot Number: G301
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/11/2016
• Supplement Report FDA Received Date: 12/02/2016
• 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: Hospitalization; Other
• Patient Age: 39 YR
• Patient Weight: 59