MAUDE Adverse Event Report: COSMAN MEDICAL CANNULA

Model Number	RFK-C101020S-P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943)
Date of Event	07/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to bsn because it was discarded by the medical facility.
Event or Problem Description
A report was received that a patient experienced elevated, itchy red bumps two to ten days after the procedure.The bumps appeared to be similar to mosquito bites.It is not known if treatment was provided.No further information can be obtained.

• Brand Name: CANNULA
• Common Device Name: CANNULA
• Manufacturer (Section D): COSMAN MEDICAL; 22 terry ave; burlington MA 01803
• MDR Report Key: 6748488
• Report Number: 3006630150-2017-02655
• Device Sequence Number: 13666669
• Product Code: GXI
• UDI-Device Identifier: 00813250010756
• UDI-Public: (01)00813250010756(11)170605(17)210512
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Type of Report: Initial
• Report Date (Section B): 07/06/2017

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 Expiration Date: 05/12/2021
• Device Model Number: RFK-C101020S-P
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2017
• Initial Report FDA Received Date: 07/27/2017
• 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: Other