MAUDE Adverse Event Report: ARTHROCARE CORP. SINU KNIT DISSOLVABLE DRESSING; SPLINT, INTRANASAL SEPTAL

Model Number	RR 600
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cellulitis (1768); Granuloma (1876); Hematoma (1884); Scar Tissue (2060); Prolapse (2475); Swelling/ Edema (4577)
Date of Event	01/01/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).Doi: govaerts j, vercruysse jp, samoy k, de groot v, jorissen m, claes j.Myospherulosis as a complication of functional endoscopic sinus surgery: a double case report.B-ent.2013;9(4):339-42.Pmid: 24597112.
Event or Problem Description
It was reported that on literature review "myospherulosis as a complication of functional endoscopic sinus surgery: a double case report", after a sinus surgery of the maxillary and ethmoidal sinuses bilaterally, in combination with a septoplasty and a conchotomy of the lower turbinates because of chronical nasal obstruction and nasal decongestant abuse, a sinu-knit with a combined corticosteroid and antibiotic ointment(terra-cortril®: hydrocortisone + oxytetracycline) was placed in the middle nasal passages.In the post-operative period, the patient presented swelling on the medial side of the right lower eyelid treated withoral antibiotics and corticosteroids, discrete mucosal prolapse at the level of the right maxillary sinus, haematoma in the right lower eyelid, pronounced inflammatory tissue swelling and granulation tissue around the inserted pds film and signs of preseptal oedema and/or cellulitis in the right eyelids, large amount of scar tissue in all layers from the dermis into the orbit and resected until healthy orbital fat and granulomas with numerous multinucleated giant cells in a dense inflammatory cell infiltrate of lymphocytes and lipid vacuoles.The swelling recurred months after the debulking procedure and is still present after two years of follow-up.

• Brand Name: SINU KNIT DISSOLVABLE DRESSING
• Common Device Name: SPLINT, INTRANASAL SEPTAL
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12986050
• Report Number: 3006524618-2021-01055
• Device Sequence Number: 17461425
• Product Code: LYA
• UDI-Device Identifier: 00817470005394
• UDI-Public: 00817470005394
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: RR 600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2021
• Supplement Date Received by Manufacturer: 03/01/2022
• Initial Report FDA Received Date: 12/13/2021
• Supplement Report FDA Received Date: 03/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown