MAUDE Adverse Event Report: COSMAN MEDICAL RADIOFREQUENCY CANNULA; RF CANNULA

Model Number	RFK-C101020S
Health Effect - Clinical Codes	Burn(s) (1757); Erythema (1840); Itching Sensation (1943)
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 on the cause of the burn due to the product not being returned to (b)(6) medical.We are continuing to pursue the return of the product for complaint evaluation.Photo was sent to (b)(6) and it shows red spots but not burns.Looks like result of needle punture or allergic reaction.Inspection of product in-house shows that all units in lot were manufactured correctly.Device not returned to company.
Event or Problem Description
The facility reported that the patient has three burns.She currently feels itchy, and has the red spots in the area.The location was on her lower back and the patch was on her calf as well.
Additional Manufacturer Narrative
Cosman engineering team evaluated the remaining inventory of rfk-c101020 s from the same lot g301 and there was no non-conformance found.Additionally, the facility sent the remaining six cannulas in unopened pouch from the same box on nov 14th, but the suspect needles were not sent, and there was no non-conformance found on the remaining needles.Related medical device was evaluated.
Event or Problem Description
The facility reported that the patient exhibited 3 burns on her back.She feels itchy and has the red spots at the location.She is currently doing ok but will keep documentation of herself.

• Brand Name: RADIOFREQUENCY CANNULA
• Common Device Name: RF CANNULA
• Manufacturer (Section D): COSMAN MEDICAL; 22 terry ave; burlington MA 01803
• MDR Report Key: 6095405
• Report Number: 3004867882-2016-00003
• Device Sequence Number: 18923321
• Product Code: GXI
• UDI-Device Identifier: 00813250010756
• UDI-Public: 813250010756
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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 Assistant
• Device Expiration Date: 04/04/2020
• Device Model Number: RFK-C101020S
• Device Catalogue Number: RFK -C101020S
• Device Lot Number: G301
• Was Device Available for Evaluation?: No
• Device Age: 8 MO
• 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: 46 YR
• Patient Weight: 68