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

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

Patient Problems Fall (1848); Bone Fracture(s) (1870); Loss of consciousness (2418); Syncope/Fainting (4411)

Event Type  Injury  

Event Description

This literature case, derived from a full text article, was received on 07-feb-2022.It described a (b)(6) female patient who developed "neurally mediated syncope associated with nasopharyngeal swab specimen collection process" (pt: syncope) and had "nondisplaced left nasal bone fracture due to the associated fall" (pt: facial bones fracture and pt: fall) post nasopharyngeal swab test for covid-19.Case report: a (b)(6) female with a past medical history of deep vein thrombosis, hypothyroidism, gastroesophageal reflux disease, and rheumatoid arthritis, and no history of presyncopal or syncopal symptoms, presented following syncope during covid-19 specimen collection by nasopharyngeal swab as part of a universal pre-procedure screening protocol.During the collection process, the patient experienced a pain in her throat and while leaning forward from a seated position to sneeze, she transiently lost consciousness and fell to the ground, resulting in midface injury.The patient quickly regained consciousness and was immediately taken to the emergency department (ed) in the same facility for further evaluation.In the ed, the patient denied prodromal symptoms prior to this episode aside from the reported pain.Laboratory results and orthostatic vitals were both within normal limits.An electrocardiogram showed sinus bradycardia but was otherwise unremarkable.Computed tomography of the head demonstrated a nondisplaced left nasal bone fracture due to the associated fall with no additional acute pathologic findings.Electrophysiology was consulted and concluded the patient experienced an isolated, neurally mediated, non-cardiogenic syncopal event and was discharged after stabilization and reassurance.She had no previous diagnosis of covid-19 and received the first and second dose of the mrna-1273 (moderna) vaccine three and four months prior to the syncopal episode, respectively.A negative nucleic acid amplification covid-19 test was returned and the patient underwent scheduled cataract surgery two days later.Author's comment: complications of nasopharyngeal swabs are important to consider when implementing universal covid-19 screening protocols.Less invasive collection methods may be warranted.This case highlights one of the potential unintended, albeit rare, consequences of the nasopharyngeal swab collection procedure.Literature citation: bloom wr, bloom td.Neurally mediated syncope triggered by covid-19 nasopharyngeal swab specimen collection: a case report.Allergy rhinol.2022;13:1-4.Company comment: a patient developed neurally mediated syncope associated with nasopharyngeal swab specimen collection process (syncope) and had nondisplaced left nasal bone fracture due to the associated fall (facial bones fracture and fall) post nasopharyngeal swab test for covid-19.Considering the case information, the role of nasopharyngeal swab cannot be ruled out and the causality of syncope, facial bones fracture, and fall is assessed as possible with nasopharyngeal swab.The case is considered serious due to medical significance of syncope and facial bones fracture.Syncope, facial bones fracture, and fall are 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: 13547334
• MDR Text Key: 290070634
• Report Number: 3015145560-2022-00003
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• 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: 02/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Female