MAUDE Adverse Event Report: FOSUN PHARMA USA INC. NASOPHARYNGEAL SWAB

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

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Type  Injury  

Event Description

This literature case, derived from an abstract, was received on 17-may-2023, along with the full-text literature article received on 24-may-2023.It described a 45-year-old female patient who developed "unilateral cerebrospinal fluid rhinorrhea" (pt: cerebrospinal fluid leakage) post nasopharyngeal swab test for covid-19.Case report: a 45-year-old woman presented with unilateral rhinorrhea.In her history, a swab test had been taken from the left nasal cavity for coronavirus disease 2019 (covid-19) a month earlier, and serous nasal drops developed shortly after testing.The patient was diagnosed with covid-19.The patient was admitted to a clinic with a serous nasal discharge from the left nostril lasting for a month.The endoscopic evaluation revealed serous rhinorrhea from the left nasal cavity, but no mass or source of the fluid was detected.Beta-2 transferrin was positive for nasal discharge.Computed tomography (ct) and magnetic resonance imaging were conducted, and no mass was found in the nasal cavity.On the other hand, bony dehiscence was possible on the left side of the ethmoid roof.An intrathecal contrast-enhanced ct scan showed contrast material leaking from the lamina cribrosa in the left olfactory groove.Endoscopic cerebrospinal fluid (csf) leak repair was planned.Before surgery, intrathecal fluorescein was infused, and the leak was identified in the left nasal cavity.The bony defect was skeletonized and repaired with septal cartilage, abdominal fat tissue, and fascia lata grafts.The patient was followed up in the hospital, prescribed ceftriaxone for 14 days, and no lumbar drainage was needed.The patient has been leakage free for 12 months postoperatively with no additional symptoms.Written informed consent was obtained from the patient.Authors' comment: in the present case, csf rhinorrhea that appeared immediately after sampling was observed, and it was noteworthy that the patient's radiological images did not have any findings compatible with any encephalocele or similar.Literature citation: uz u, gunhan k, pabuscu y, mutlu s, kamiloglu u.Extraordinary complication of covid-19 swab testing: csf rhinorrhea.J craniofac surg.2023 may;34(3):e325-6.Company comment: a female patient developed unilateral cerebrospinal fluid rhinorrhea (cerebrospinal fluid leakage) post nasopharyngeal swab test for coronavirus disease 2019 covid-19.Further information regarding the events and medical history is limited.Considering the limited 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 which led to hospitalization of the patient and need of intervention.Cerebrospinal fluid leakage is 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: 17017793
• MDR Text Key: 316102623
• Report Number: 3015145560-2023-00005
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Age: 45 YR
• Patient Sex: Female