MAUDE Adverse Event Report: ARTHROCARE CORP. SINU FOAM; SPLINT, INTRANASAL SEPTAL

Catalog Number	RR 650
Health Effect - Clinical Code	Fungus (1872)
Date of Event	09/10/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that another surgery had to be made to remove sinus foam since this caused growth of fungus in nasal cavity.
Additional Manufacturer Narrative
Without the return of the product, laboratory results or the requested clinical information we are unable to determine if the patient followed the instruction for use for the stammberger sinu foam.Proper use of the netti pot, or if the reported secretions prior to the 2018 procedure was retained sinu foam.Additionally, there is no evidence to support the smith and nephew product contributed to the reported fungal growth in the patient¿s nasal cavity.Therefore, a root cause of the reported event cannot be determined.The occurrence of nasal cysts and benign polyps are common in patients with chronic sinusitis.The future impact to the patient cannot be determined.
Additional Manufacturer Narrative
The product, used for treatment, was not returned for evaluation.A relationship, if any, between the product and the reported event could not be determined since the product was not returned for evaluation.Visual inspection and functional testing could not be performed because the product in question was not returned for evaluation.Thus, the customer¿s complaint could not be verified, nor could a root cause be determined with confidence.It is possible the product was not sufficiently hydrated with lactated ringer solution or water, which could delay the timeline for product dissolution.It is also possible the patient did not irrigate properly after implantation.

• Brand Name: SINU FOAM
• Common Device Name: SPLINT, INTRANASAL SEPTAL
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8064155
• Report Number: 3006524618-2018-00590
• Device Sequence Number: 1947046
• Product Code: LYA
• UDI-Device Identifier: 00817470000412
• UDI-Public: 00817470000412
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/02/2019

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: Health Professional
• Device Catalogue Number: RR 650
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 12/18/2018; 12/18/2018
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 12/20/2018; 01/02/2019
• 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