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); Head Injury (1879); Encephalitis (2429)

Event Type  Injury  

Event Description

The literature case was derived from table 1 of the master article received on 10-apr-2023 along with the full-text literature article received on 13-apr-2023.It described a 36-year-old female patient who developed "iatrogenic skull base injury" (pt: head injury), "bacterial meningoencephalitis" (pt: meningoencephalitis bacterial) and "iatrogenic cerebrospinal fluid (csf) leak" (pt: cerebrospinal fluid leakage) post nasopharyngeal swab test for covid-19.Case report: a 36-year-old female patient presented to the emergency department with fever, headache, altered level of consciousness and agitation.Patient provided history of headache and clear watery rhinorrhea from the right side of the nose after nasopharyngeal swab for covid-19 started four months prior to her presentation.She had a significant past medical history of idiopathic intracranial hypertension (iih) that was evident by magnetic resonance imaging (mri) in 2018 with empty sella turcica sign.The patient underwent sinus computed tomography (ct), which demonstrated opacification of the right sphenoid sinus.Brain mri showed a possible csf leak at the right sphenoid sinus.The lumbar puncture was done, and fluid was sent for analysis to rule out meningitis.Fluid from nasal cavity was collected and sent for beta-2-transferrin testing and confirmed to be positive for csf.Meningoencephalitis, likely bacterial, was diagnosed based on csf results.The decision was made to start the patient on intravenous antibiotics.The patient progressed appropriately after the treatment and was discharged after thirteen days of admission.After that, the patient was followed in the clinic and improved with no more csf rhinorrhea with conservative non-surgical management.Authors' comment: in this case, an iatrogenic csf leak after the swab was identified in a patient with iih.Her case was complicated with meningitis which resolved after intravenous antibiotics.However, underlying conditions that cause an increase in intracranial pressure such as iih could result in spontaneous csf leaks.Literature citation: asiri m, alhedaithy r, alnazer z.Cerebrospinal fluid leak post covid-19 nasopharyngeal swab for a patient with idiopathic intracranial hypertension: a case report.J surg case rep.2021;10:1-3.The citation of this literature article was found in table 1 of the master literature article received on 10-apr-2023 with the following citation: literature citation: pandit as, vasilica am, reka a, mallon d, toma ak, marcus hj.Covid-19 nasopharyngeal swab and cribriform fracture.Ann r coll surg engl.2023:1-6.Company comment: a 36-year-old female patient developed iatrogenic skull base injury (head injury), bacterial meningoencephalitis (meningoencephalitis bacterial) and iatrogenic cerebrospinal fluid leak (cerebrospinal fluid leakage) post nasopharyngeal swab test for covid-19.In response to the event, patient was hospitalized and was discharged after thirteen days of admission.Considering the case information, the role of nasopharyngeal swab cannot be ruled out and the causality of head injury, meningoencephalitis bacterial and cerebrospinal fluid leakage is assessed as possible (confounded by idiopathic intracranial hypertension).The case is considered serious due to medical significance of head injury, meningoencephalitis bacterial and cerebrospinal fluid leakage which led to hospitalization of the patient.Head injury, meningoencephalitis bacterial and cerebrospinal fluid leakage are unlisted as per uspi.

• Brand Name: NASOPHARYNGEAL SWAB
• Type of Device: NASOPHARYNGEAL SWAB
• Manufacturer (Section D): FOSUN PHARMA USA INC.; suite 204; 104 camegie center; princeton NJ 08540
• Manufacturer Contact: kathy zhang ; suite 204; 104 camegie center; princeton, NJ 08540
• MDR Report Key: 16796236
• MDR Text Key: 313833371
• Report Number: 3015145560-2023-00003
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): N
• Reporter Country Code: SA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Hospitalization; Other
• Patient Age: 36 YR
• Patient Sex: Female