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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); Nasal Obstruction (2466)
Event Type  Injury  
Event Description
This literature case, derived from an abstract, was received on 21-jun-2023.It described a 47-year-old male patient who developed "frontal brain abscess" (pt: brain abscess) post nasopharyngeal swab test for covid-19 (corona virus disease- 2019).Case report: a 47-year-old male diabetic patient with a positive medical history for immune thrombocytopenic purpura (itp) developed a frontal brain abscess one week after the swabbing procedure and was treated with systemic antibiotics followed by a successful functional endoscopic sinus surgery.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 47-year-old male diabetic patient with a positive medical history for immune thrombocytopenic purpura developed a frontal brain abscess one week after swabbing procedure using the nasopharyngeal swab for coronavirus disease 2019 (covid-19) testing.Considering the case information, the role of nasopharyngeal swab cannot be ruled out and the causality of frontal brain abscess 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 47-year-old male patient who developed "frontal brain abscess" (pt: brain abscess) post nasopharyngeal swab test for covid-19 (corona virus disease- 2019).Case report: a 47-year-old male diabetic patient with a positive medical history for immune thrombocytopenic purpura (itp) developed a frontal brain abscess one week after the swabbing procedure and was treated with systemic antibiotics followed by a successful functional endoscopic sinus surgery.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 (fos202306-000009 and fos202306-000010) were created and linked in the database.Company comment: a 47-year-old male diabetic patient with a positive medical history for immune thrombocytopenic purpura developed a frontal brain abscess one week after swabbing procedure using the nasopharyngeal swab for coronavirus disease 2019 (covid-19) testing.Considering the case information, the role of nasopharyngeal swab cannot be ruled out and the causality of frontal brain abscess 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 47-year-old male patient who developed "frontal brain abscess" (pt: brain abscess), "mild nasal congestion" (pt: nasal congestion) and "severe sinusitis" (pt: sinusitis) post nasopharyngeal swab test for covid-19 (corona virus disease- 2019).Case report: a 47-year-old male diabetic patient came to attention after he was being referred from a peripheral hospital for assessment of pleuritic and gradual left sided chest pain of 3 day-duration associated with general weakness and feverish sensation.Past medical history of the patient was significant for immune thrombocytopenic purpura (itp) and diabetes mellitus on hypoglycemic medications for 5 years.The patient reported no personal and/or family history of cancer; any acute, repeat, or discontinued medications; any allergies; any chronic or autoinflammatory diseases; any genetic or psychosocial issues; and a free past surgical history.Upon admission, physical assessment revealed a well, alert, conscious, and oriented patient with stable vital signs except for low grade fever with a 38 c.Nasopharyngeal swab for covid-19 infection was taken and it was negative.The patient claimed that insertion of the swab into the nasal cavity was intensely difficult and painful on the right side.Following the procedure, he had a mild nasal congestion but otherwise, there were no complications, and the swab was withdrawn completely without retaining any of its parts.A computed tomography (ct) scan showed a few cavitary lesions with air-fluid level in the left upper lobe of the chest consistent with lung abscesses and pleural effusion drained via chest tube.However, one week later, the patient returned to the hospital back with complaints of right sided, intermittent and gradually increasing headache not relived by pain reliver.He denied any history of facial trauma or nasal surgery.There was no history of any neurological deficit, nausea, vomiting, loss of consciousness, or seizures.Physical examination revealed a confused patient with tenderness over the right frontal side.A brain magnetic resonance imaging (mri) with contrast was performed and showed right frontal brain abscess, right retro-orbital abscess and almost complete obstruction of the right frontal, ethmoidal, maxillary and sphenoid sinuses representing severe sinusitis.The patient's findings were attributed to the history of uncomfortable nasopharyngeal swab test.Then the patient was given intravenous antibiotic treatment and underwent a successful functional endoscopic sinus surgery (fess).He was followed-up for 2 months with significant improvement in his clinical status without any reported complications, recurrent headache, adverse events, or re-admissions.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 47-year-old patient who developed frontal brain abscess, mild nasal congestion and severe sinusitis one week after swabbing procedure using the nasopharyngeal swab for coronavirus disease 2019 (covid-19) testing.In response to the event, the patient was given intravenous antibiotic treatment and underwent a successful functional endoscopic sinus surgery.Considering the case information, the role of nasopharyngeal swab cannot be ruled out and the causality of frontal brain abscess, nasal congestion and sinusitis is assessed as possible.The case is considered serious due to medical significance of frontal brain abscess and sinusitis which led to hospitalization of the patient and need of intervention.Frontal brain abscess, nasal congestion and sinusitis are 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 Key17254438
MDR Text Key318438199
Report Number3015145560-2023-00006
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
Patient Outcome(s) Hospitalization; Other; Required Intervention;
Patient Age47 YR
Patient SexMale
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