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

Device Problem Output Problem (3005)

Patient Problems Cerebrospinal Fluid Leakage (1772); Skull Fracture (2077)

Event Type  Injury  

Event Description

This literature case, derived from a full text article, was received on 25-jan-2022.It described a (b)(6) female patient who developed cerebrospinal fluid (csf) rhinorrhoea (pt: cerebrospinal fluid leakage) and covid-19 swab-related skull base injury (pt: skull fractured base) post nasopharyngeal swab test for covid-19.Case report: a (b)(6) woman was referred to the ear, nose and throat department with confirmed cerebrospinal fluid (csf) rhinorrhoea.She was recently treated for proven bacterial meningitis, having presented to a regional hospital with headache, nausea and photophobia two months previously.The patient precisely recalled the onset of unilateral clear rhinorrhoea, which occurred within hours of an "extremely painful" coronavirus disease 2019 (covid-19) swab test.This occurred approximately 48 hours prior to presentation to the emergency department.She had no other historical or medical risk factors for a csf fistula (e.G., previous surgery, trauma) nor harboured any stigmata of idiopathic intracranial hypertension.Intra-operative evaluation (by computed tomography scan of the sinuses and endoscopy) confirmed a small, well demarcated defect (2-3 mm) in the left anterior skull base in the posterior cribriform plate.The defect was successfully repaired with a fat plug and free mucosa overlay graft.She made a full recovery and remains leak-free.Given the historical description, time frame and clinical findings, it was believed that the injury to be a complication of the covid-19 swab.Author's comment: this case highlights the occurrence of skull base injury during nasal swabbing.This represents a severe but rare complication of mass testing.Skull base injury and cerebrospinal fluid leak are a possible but very rare complication from coronavirus disease 2019 (covid 19) swab testing.Literature citation: mistry sg, walker w, earnshaw j, cervin a.Covid-19 swab-related skull base injury.Med j aust.2021 jun;214(10):457-9e1.The citation of this literature article was found in discussion of the master literature article received on 21-jan-2022 with the following citation: 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.2021;21:100370.Company comment: a patient had covid-19 swab-related skull base injury (skull fractured base) and developed cerebrospinal fluid rhinorrhoea (cerebrospinal fluid leakage) post nasopharyngeal swab test for covid-19.In response to the events, patient underwent surgical intervention.Considering the case information, the role of nasopharyngeal swab cannot be ruled out and the causality of skull fractured base and cerebrospinal fluid leakage is assessed as possible with nasopharyngeal swab.The case is considered serious due to medical significance of the events and required intervention.Skull fractured base and cerebrospinal fluid leakage are unlisted as per uspi.

• Brand Name: MEDICAL SWAB
• Type of Device: NASOPHARYNGEAL SWAB
• Manufacturer (Section D): FOSUN PHARMA USA INC.; suite 204; 104 carnegie center; princeton NJ 08540
• MDR Report Key: 13467312
• MDR Text Key: 289512071
• Report Number: 3015145560-2022-00002
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2022
• 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: 01/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 67 YR
• Patient Sex: Female