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); Encephalocele (4402)

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 59-year-old male patient who developed "left middle cranial fossa encephalocele herniating into the sphenoid sinus" (pt: encephalocele), had "cerebrospinal fluid (csf) leak" (pt: cerebrospinal fluid leakage), and "skull base defect" (pt: head injury) post nasopharyngeal swab test for covid-19.Case report: a 59-year-old male presented to emergency department (ed) in jul-2020 with unilateral rhinorrhoea present for two months.He previously had presented to ed in may-2020 with a runny nose from both nostrils and cough.He was sent to hospital covid clinic for a nasopharyngeal swab.The test was conducted by a registered nurse, and it was negative.The patient represented because his flu like symptoms subsided but the rhinorrhoea from his left nostril persisted.His past medical history was significant for hypertension, type 2 diabetes mellites and dyslipidaemia.He denied any history of major skull base trauma, recurrent sinusitis, meningitis, or previous nasal/sinus surgery.He denied any headaches or raised increased intracranial pressure (icp) symptoms.Clinical exam revealed persistent nasal discharge of clear fluid on bending forward from the left nostril.The rate of fluid egress increased with valsalva.His case was discussed with the on-call ent specialists, and they requested a beta-2-transferrin as well as a computerised tomogram (ct) brain and sinuses.The ct brain showed communication between the left middle cranial fossa with the left sphenoid sinus via a defect in the lateral wall of the sella turcica with the left temporal horn being drawn through the defect.His beta-2-transferrin returned as positive, and the patient was referred to neurosurgery for combined management.He was promptly referred to ophthalmology for formal visual testing and fundoscopy which showed no findings consistent with raised icp.His magnetic resonance imaging (mri) subsequently confirmed a skull base defect in middle cranial fossa with an encephalocele herniating through it.It appeared that the temporal horn was being drawn through the defect as well.He underwent a traumatic lumbar puncture (lp) which showed an opening pressure of 5 cm h20 with 780 red cells and 2 white cells with a 50/50 differential for polymorphonuclear cells and mononuclear cells.There were no organisms noted on gram stains well as extended polymerase chain reaction (pcr).Given the lack of raised pressure symptoms in history and exam as well as low opening pressure, the patient underwent excision of encephalocele and skull base repair endoscopically with a vascularised nasoseptal flap without any plans for permanent csf diversion.The operative specimen resected from the sphenoid sinus contained a mixture of mature astrocytes and neurons with reactive microglia confirming the clinical diagnosis of encephalocele.The patient was discharged, day 1 with oral antibiotics.He remained asymptomatic for 25 days then had recurrence of csf leak with associated headaches.This required repeat endoscopic repair with placement of a dumbbell fat graft and instillation of a lumbar drain.The lumbar drain remained till day 4 and then removed the patient was discharged day 6 with no leak.The patient remained asymptomatic with no leak at 2 month follow up.Author's comment: in this case it was believed that the patient had a pre-existing defect and the nasal swab inserted at an incorrect angle and depth disrupted the mucosa surrounding the encephalocele causing the csf leak.This case showcases that despite samples being obtained by medical professions, adverse events may still occur and highlights the importance of education for safe administration of nasal swabs with understanding of the nasal anatomy as well.Literature citation: rajah j, lee j.Csf rhinorrhoea post covid-19 swab: a case report and review of literature.J clin neurosci.2021;86:6-9.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 59-year-old male patient developed left middle cranial fossa encephalocele herniating into the sphenoid sinus (encephalocele), cerebrospinal fluid (csf) leak (cerebrospinal fluid leakage) and skull base defect (head injury) post nasopharyngeal swab test for covid-19.In response to the event, patient was hospitalized.She underwent excision of encephalocele and skull base repair endoscopically.This patient was discharged with oral antibiotics.Considering the case information, the role of nasopharyngeal swab cannot be ruled out and the causality of encephalocele, cerebrospinal fluid leakage and head injury is assessed as possible.The case is considered serious due to medical significance of encephalocele, cerebrospinal fluid leakage and head injury which led to hospitalization of the patient and need of intervention.Encephalocele, cerebrospinal fluid leakage and head injury 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: 16796422
• MDR Text Key: 313835293
• Report Number: 3015145560-2023-00002
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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): Other; Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male