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

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Fever (1858); Low Blood Pressure/ Hypotension (1914); Infiltration into Tissue (1931); Ventilator Dependent (2395); Hematuria (2558); Epistaxis (4458)

Event Type  Injury  

Event Description

This literature case, derived from an abstract, was received on 23-jun-2021.It described an (b)(6)-year-old female who developed "profuse epistaxis" (pt: epistaxis) after she received a polymerase chain reaction (pcr) nasopharyngeal swab for testing of coronavirus disease 2019 (covid-19).Case report: an (b)(6)-year-old female presented from home with a complaint of hematuria.Her past medical history includes rheumatic heart disease status post repair on warfarin, atrial fibrillation and stroke.Vital signs were normal.She had benign head and neck exam, clear lung sounds, an irregular heart rhythm and a normal abdominal exam.Labs were at baseline with hemoglobin of 10.4.Chest x-ray and computed tomography (ct) of abdomen were unremarkable.She received a pcr nasopharyngeal swab in the emergency room and subsequently developed profuse epistaxis.Initial nasal packing and afrin (oxymetazoline) sprays failed to control the bleeding and she required emergent intubation for airway protection.She also needed vasopressors due to hypotension.Repeat hemoglobin was 7.5 and lactic acid was 10.4.Bleeding eventually stopped after continuous nasal packing, transfusional support and intravenous (iv) vitamin k (phytonadione).In the following days, she developed fever, leukocytosis and lung infiltrates.She received empiric antibiotic coverage, although no growth from cultures.Endoscopy findings were consistent with ischemic colitis.Later, she stabilized hemodynamically but was unable to be liberated from the ventilator.She was discharge to a long-term care facility after 43 days of stay.Author's comment: nasopharyngeal swabs are the mainstay of testing for covid-19, however, little has been discussed regarding its procedural risks.Common adverse effects include headaches, nasal pain, ear discomfort and rhinorrhea.Recent studies have suggested that the incidence of epistaxis can be as high as 10 percent after the test.This case vividly demonstrated that even the most common procedure can result in devastating outcomes.As such, health care providers should be cognizant of these complications and consider alternative testing method when possible.Literature citation: meng w, miller ra, pate s, nanavati sm, patel r, khatatneh a, et al.From a cotton bud to a pool of blood covid-19 testing, a double-edged sword? 2021 may.Am j respir crit care med.203(9).Company comment: a patient developed profuse epistaxis (epistaxis) after she received a polymerase chain reaction (pcr) nasopharyngeal swab for testing of coronavirus disease 2019 (covid-19).This patient was on warfarin for rheumatic heart disease status post repair.In response to the event, nasal packing was done along with use of afrin sprays and patient was hospitalized.She underwent emergent intubation for airway protection and was treated with vasopressors, transfusional support and vitamin k.This patient was discharged to long term facility care after 43 days of hospitalization.Considering the case information, the role of nasopharyngeal swab cannot be ruled out and the causality of epistaxis is assessed as possible.The case is considered serious due to medical significance of epistaxis which led to hospitalization of the patient and need of intervention.Epistaxis is unlisted as per uspi.

• Brand Name: NASOPHARYNGEAL SWAB
• Type of Device: NASOPHARYNGEAL SWAB
• Manufacturer (Section D): FOSUN PHARMA USA INC.; suite 204; 104 carnegie center; princeton NJ 08540
• Manufacturer Contact: kathy zhang ; suite 204; 104 carnegie center; princeton, NJ 08540
• MDR Report Key: 12133285
• MDR Text Key: 260863549
• Report Number: 3015145560-2021-00003
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): N
• PMA/PMN Number: KXG
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 06/23/2021
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 80 YR