MAUDE Adverse Event Report: COSMAN MEDICAL CANNULA, 10CM,5MM TIP,21G SHARP STRAIGHT

Model Number	CC10521
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Swelling (2091)
Date of Event	09/18/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
A report was received that following a radiofrequency treatment, the patient experienced a location reaction on the site of the puncture.The physician noted there was red swelling around the two points of insertion.The physician reported that she was not sure that the reaction had to do with the needles, and assessed that it could have also been due to the local anesthetic.It is not known if the patient was administered any medical treatment for the allergic reaction.The patient will undergo skin testing.
Additional Manufacturer Narrative
Correction to f/u #1 mdr should have been 28-nov-2017.
Event or Problem Description
A report was received that following a radiofrequency treatment, the patient experienced a location reaction on the site of the puncture.The physician noted there was red swelling around the two points of insertion.The physician reported that she was not sure that the reaction had to do with the needles, and assessed that it could have also been due to the local anesthetic.It is not known if the patient was administered any medical treatment for the allergic reaction.The patient will undergo skin testing.
Additional Manufacturer Narrative
Additional information was received that the patient had a positive skin test for nickel sulphate.The physician reported that it is possible that the device had a role since there is nickel in the cannula.It was also noted that the patient had a positive intracutaneous test on lidocaine, which was the local anesthetic that was used.The physician assessed that the patient's reaction was most likely due to the lidocaine.
Event or Problem Description
A report was received that following a radiofrequency treatment, the patient experienced a location reaction on the site of the puncture.The physician noted there was red swelling around the two points of insertion.The physician reported that she was not sure that the reaction had to do with the needles, and assessed that it could have also been due to the local anesthetic.It is not known if the patient was administered any medical treatment for the allergic reaction.The patient will undergo skin testing.

• Brand Name: CANNULA, 10CM,5MM TIP,21G SHARP STRAIGHT
• Common Device Name: CANNULA
• Manufacturer (Section D): COSMAN MEDICAL; 22 terry ave; burlington MA 01803
• MDR Report Key: 6946636
• Report Number: 3006630150-2017-04160
• Device Sequence Number: 16446064
• Product Code: GXI
• UDI-Device Identifier: 00813250012477
• UDI-Public: 00813250012477
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K060799
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/04/2017

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: CC10521
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/18/2017
• Supplement Date Received by Manufacturer: 11/05/2017; 11/05/2017
• Initial Report FDA Received Date: 10/12/2017
• Supplement Report FDA Received Date: 11/28/2017; 12/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1