MAUDE Adverse Event Report: FOSUN PHARMA USA INC NASOPHARYNGEAL SWAB

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cerebrospinal Fluid Leakage (1772); Headache (1880); Pain (1994); Encephalocele (4402)

Event Type  Injury  

Event Description

This literature case, derived from a full text scientific article, was received on 09-mar-2021.It described a (b)(6) female patient who had traumatic skull base injury during a nasopharyngeal swab for covid-19 resulting in cerebrospinal fluid rhinorrhea (pt: cerebrospinal fluid leakage and head injury).Case report: a (b)(6) female presented to the hospital after experiencing severe pain during a nasopharyngeal (np) swab for coronavirus disease 2019 (covid-19) followed by 2 days of persistent clear watery rhinorrhea that worsened with leaning forward.She also noticed persistent headache and metallic tasting postnasal drip.The patient had no history of head trauma or surgery.She was otherwise healthy.Initial examination, including nasal endoscopy, was unremarkable other than a small amount of clear right-sided nasal drainage.The patient underwent a computed tomography scan, which demonstrated a subtle defect in the posterior right cribriform plate.She then underwent magnetic resonance imaging, which demonstrated a small encephalocele projecting from the olfactory fossa of the right superior nasal cavity.It was decided to explore and perform a skull base repair.The patient was taken to the operating room the following day for endoscopic endo-nasal approach with stereotactic navigation.The posterior cribriform and ethmoid roof were not visualized with lateralization of the middle turbinate, and so it was removed, and its mucosa harvested for a free graft.This allowed visualization of a small encephalocele just anterior to the sphenoid rostrum at the junction between the cribriform and ethmoid roof.Valsalva resulted in visible pulsation and increased flow of cerebrospinal fluid (csf).The surrounding bone and mucosa were removed, exposing the dura.The encephalocele was reduced with bipolar cautery.The free mucosal graft was then placed over the expanse of the exposed dura and csf leak.Cessation of the csf leak was confirmed.Surgicel was then placed around the margin of the graft, and dural sealant was applied.This was followed by gelfoam, and a sponge packing.The patient was placed on sinus precautions and observed overnight.She progressed appropriately and was discharged the following day.She was seen in follow-up on postoperative day 9 and reported resolution of all symptoms.The nasal sponge was removed at that time.Nasal endoscopy demonstrated appropriately healing mucosa and no signs of a persistent csf leak.Author's comment: csf leak should be considered in patients with watery rhinorrhea or salty or metallic taste postnasal drip following an np swab.This case highlights the need for education of proper np swab technique for healthcare providers and education of the signs and symptoms of csf rhinorrhea for patients.Furthermore, alternate testing methods should be considered in patients with known distortions in nasal or skull base anatomy, history of sinus or skull base surgery, or conditions that may pre-dispose the patient to skull base erosion.Literature citation: paquin r, ryan l, vale fl, rutkowski m, byrd jk.Csf leak after covid[?]19 nasopharyngeal swab: a case report.Laryngoscope.2021;00:1-3.Company comment: a patient had traumatic skull base injury during a nasopharyngeal swab for covid-19 resulting in cerebrospinal fluid rhinorrhea (cerebrospinal fluid leakage and head injury).This patient had no history of head trauma or surgery, and found to have a subtle defect in the posterior right cribriform plate after nasopharyngeal swab was performed, which resulted in cerebrospinal fluid leakage.In response to these events, patient was successfully treated in the hospital with a surgical exploration and performed skull base repair.Considering the case information, the causality of cerebrospinal fluid leakage and head injury is assessed as possible with nasopharyngeal swab.The case is considered serious due to medical significance of events cerebrospinal fluid leakage and head injury which resulted in hospitalization and required a surgical intervention.The events cerebrospinal fluid leakage and head injury are unlisted.

• Brand Name: NASOPHARYNGEAL SWAB
• Type of Device: NASOPHARYNGEAL SWAB
• Manufacturer (Section D): FOSUN PHARMA USA INC; suite 204; 104 carnegie center; princeton NJ 08540
• MDR Report Key: 11536871
• MDR Text Key: 241396782
• Report Number: 3015145560-2021-00001
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2021
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 38 YR