MAUDE Adverse Event Report: FOSUN PHARMACEUTICALS USA MEDICAL SWAB; NASOPHARYNGEAL SWAB

Device Problem Use of Device Problem (1670)

Patient Problems Cerebrospinal Fluid Leakage (1772); Laceration(s) (1946)

Event Type  Injury  

Event Description

This literature case, derived from a full text article, was received on 21-jan-2022.It described a (b)(6) year-old female patient in whom rhinorrhea was caused by a csf leakage (pt: cerebrospinal fluid leakage) post nasopharyngeal swab test for covid-19 (corona virus disease- 2019).Case report: a (b)(6) year-old woman presented with unilateral rhinorrhea on the right, progressive headache, and photophobia from a week ago.The patient had recently taken covid-19 nasopharyngeal swab test as she had contact with a positive covid-19 patient.Shortly after, she experienced rhinorrhea accompanied by a headache.She had no history of similar symptoms before.Her medical history was also negative for any types of surgery and illnesses.In physical examination, she had no abnormal findings other than clear rhinorrhea from the right side.The drained fluid was positive for beta-2 transferrin, proving that her rhinorrhea was caused by a cerebrospinal fluid (csf) leakage.She underwent contrast magnetic resonance venography with the suspicion of idiopathic intracranial hypertension, but the results were normal and lumbar puncture showed intracranial pressure (icp) of 11 mmhg.On computed tomography (ct) scan, there was not any obvious finding suggestive of a meningocele or skull base fracture.On cisternography, csf leakage was observed in right anterior ethmoid sinus.She was enlisted for an endoscopic surgical repair of the defect.Before the operation, intrathecal fluorescein was infused through a lumbar drain to visualize the csf leakage site during the operation.During the operation, the defect was sealed using fat and fascia lata.The patient's icp was measured two weeks and four weeks after the operation and was normal in both cases.In a follow-up visit two months after surgery, the patient was good and did not have any complaints.Author's comment: the case illustrated those individuals performing nasopharyngeal swab testing should do the test gently and take a brief history from patients regarding prior surgical intervention, or pathology that distorts normal nasal anatomy, before performing the test.This would reduce complications caused by this procedure and lower the risk of skull base erosions.Patients should be educated on different adverse events of nasopharyngeal swab testing and their associated symptoms.It was recommended that when performing a nasopharyngeal swab test, in case of any resistance, the healthcare staff should immediately stop the procedure and consider anatomical anomalies.An alternative test might be needed if nasopharyngeal test seems impossible.Literature citation: jafari a, samadian m, maroufi sf, taheri ms.Csf rhinorrhea after nasopharyngeal swab testing for covid-19: a case report and review of literature.Otolaryngol case rep.(b)(4).Company comment: a patient developed rhinorrhea caused by a csf leakage (cerebrospinal fluid leakage) post nasopharyngeal swab test for covid-19.In response to the event, patient underwent endoscopic surgical intervention.Considering the case information, the role of nasopharyngeal swab cannot be ruled out and the causality of cerebrospinal fluid leakage is assessed as possible with nasopharyngeal swab.The case is considered serious due to medical significance of cerebrospinal fluid leakage and required intervention.Cerebrospinal fluid leakage is unlisted as per uspi.

• Brand Name: MEDICAL SWAB
• Type of Device: NASOPHARYNGEAL SWAB
• Manufacturer (Section D): FOSUN PHARMACEUTICALS USA; suite 204; 104 carnegie center; princeton NJ 08540
• MDR Report Key: 13450354
• MDR Text Key: 289273948
• Report Number: 3015145560-2022-00001
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): N
• Reporter Country Code: IR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• 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: 01/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female