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U.S. Department of Health and Human Services

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

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FOSUN PHARMA USA INC. NASOPHARYNGEAL SWAB Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Pain (1994); Nasal Obstruction (2466)
Event Type  Injury  
Event Description
This literature case, derived from an abstract, was received on 21-jun-2023.It described a female patient in her 40s who had a "painful nasal covid-19 testing" (pt: rhinalgia and pt: procedural pain) and developed "frontal brain abscess" (pt: brain abscess) post nasopharyngeal swab test for covid-19 (corona virus disease- 2019).Case report: a hypertensive female patient in her 40s developed a frontal brain abscess on the same side as painful nasal covid-19 testing.Systemic antibiotics were used to treat the patient.Author's comment: brain abscess complications are considered one of the extremely rare complications, with only a few cases reported in the literature.Appropriate approaches that depend on adequate anatomical knowledge are necessary for practitioners to perform nasopharyngeal covid-19 testing.Literature citation: shrateh on, abugharbieh y, al-fallah o.Brain abscess as a complication of nasopharyngeal covid-19 swab testing: two case reports and a literature review.Int j surg case rep.2023 jul;108.Based on the available information, two individual case safety reports (b)(4) were created and linked in the database.Company comment: a hypertensive female patient in her 40s developed a frontal brain abscess on the same side as painful nasal covid-19 testing (rhinalgia and procedural pain).Considering the case information, the role of nasopharyngeal swab cannot be ruled out and the causality of frontal brain abscess, rhinalgia, and procedural pain is assessed as possible.The case is considered serious as per medical assessment.Frontal brain abscess is unlisted as per uspi.
 
Event Description
This literature case, derived from an abstract, was received on 21-jun-2023.It described a female patient in her 40s who had a "painful nasal covid-19 testing" (pt: rhinalgia and pt: procedural pain) and developed "frontal brain abscess" (pt: brain abscess) post nasopharyngeal swab test for covid-19 (corona virus disease- 2019).Case report: a hypertensive female patient in her 40s developed a frontal brain abscess on the same side as painful nasal covid-19 testing.Systemic antibiotics were used to treat the patient.Author's comment: brain abscess complications are considered one of the extremely rare complications, with only a few cases reported in the literature.Appropriate approaches that depend on adequate anatomical knowledge are necessary for practitioners to perform nasopharyngeal covid-19 testing.Literature citation: shrateh on, abugharbieh y, al-fallah o.Brain abscess as a complication of nasopharyngeal covid-19 swab testing: two case reports and a literature review.Int j surg case rep.2023 jul;108.Based on the available information, two individual case safety reports (b)(4) were created and linked in the database.Company comment: a hypertensive female patient in her 40s developed a frontal brain abscess on the same side as painful nasal covid-19 testing (rhinalgia and procedural pain).Considering the case information, the role of nasopharyngeal swab cannot be ruled out and the causality of frontal brain abscess, rhinalgia, and procedural pain is assessed as possible.The case is considered serious as per medical assessment.Frontal brain abscess is unlisted as per uspi.Follow-up information, derived from the full-text scientific literature article, was received on 28-jun-2023.It described a female patient who developed "right frontal brain abscess" (pt: brain abscess), "mild nasal congestion" (pt: nasal congestion) and "severe right sided sinusitis" (pt: sinusitis) post nasopharyngeal swab test for covid-19 (corona virus disease- 2019).Case report: a healthy female in her 40s presented to the emergency department due to severe right peri-orbital headache.The pain was sudden in onset, intermittent started one week ago and not relived by ibuprofen, but now it became constant, throbbing, and increasing in intensity.It was associated with mild tinnitus.The patient denied any nausea, vomiting, sweating, motor and/or sensory deficits, visual disturbances, meningeal or cerebellar signs, altered mental status, and/or convulsions.Past medical history was unremarkable except for controlled hypertension.Past surgical history was free.Physical evaluation of the patient revealed a low-grade fever, marked tenderness over the right side of the forehead, and mild right eye proptosis.The patient had a nasopharyngeal swab test before two weeks which was positive for covid-19.The swab test was uncomfortable, and the patient attempted to withdraw the swab during the procedure, which was complicated by mild nasal congestion, and urge to cough and sneeze.A computed tomography (ct) scan was performed, and it showed severe right sided sinusitis and retro-orbital inflammation.An magnetic resonance imaging (mri) was done and revealed a right frontal brain abscess at the same side of nasopharyngeal swab and sinusitis.The result of nasal cavity biopsy was mucormycosis.The patient was treated with intravenous antibiotics.Then she was referred to another hospital for orbito-maxillo-facial intervention.Additional laboratory data included axial brain ct scan showed of faint hypodense area suggestive of brain abscess, retro-orbital cellulitis manifested by fat stranding and haziness and severe right ethmoidal sinusitis.Author's comment: nasopharyngeal swabs have been considered a safe and accurate screening and diagnostic procedure for covid-19; however, adequate anatomical knowledge of the nasal cavity and clinical expertise are essential for not only reliable examination to reduce the virus spread but additionally to protect the patients from avoidable but frequently underestimated and potentially life-threatening complications such as the development of a brain abscess.Authors affirm the significance of the educational training programs, especially for frontliners, for improving their skill acquisition in covid-19 testing and other nasal swab applications in order to mitigate the incidence of the aforementioned complications.Literature citation: shrateh on, abugharbieh y, al-fallah o.Brain abscess as a complication of nasopharyngeal covid-19 swab testing: two case reports and a literature review.Int j surg case rep.2023 jul;108.Company comment: this case concerns a female patient who developed a frontal brain abscess on the same side as painful nasal covid-19 testing (rhinalgia and procedural pain), mild nasal congestion and severe right sided sinusitis post nasopharyngeal swab test for covid-19 (corona virus disease- 2019).In response to the event, the patient was treated with intravenous antibiotics and she underwent orbito-maxillo-facial intervention.Considering the case information, the role of nasopharyngeal swab cannot be ruled out and the causality of frontal brain abscess, rhinalgia, procedural pain, nasal congestion and sinusitis is assessed as possible.The case is considered serious due to medical significance of brain abscess, sinusitis which led to hospitalization of the patient and need of intervention.Frontal brain abscess is unlisted as per uspi.
 
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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 
MDR Report Key17256892
MDR Text Key318438280
Report Number3015145560-2023-00007
Device Sequence Number1
Product Code KXG
Combination Product (y/n)N
Reporter Country CodeIS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/28/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/28/2023
Patient Sequence Number1
Treatment
IBUPROFEN
Patient Outcome(s) Hospitalization; Other; Required Intervention;
Patient SexFemale
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