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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 Cerebrospinal Fluid Leakage (1772); Encephalopathy (1833); Meningitis (2389)
Event Type  Injury  
Event Description
The literature case was derived from table 1 of the master article received on 10-apr-2023 along with the full-text literature article received on 13-apr-2023.It described a 54-year-old female patient who developed "csf leak" (pt: cerebrospinal fluid leakage), "acute streptococcal meningitis" (pt: meningitis streptococcal), "ruptured congenital meningocele" (pt: meningocele) and "mild encephalopathy" (pt: encephalopathy) post nasopharyngeal swab test for covid-19.Case report: a 54-year-old obese female with a history of antiphospholipid syndrome on apixaban and recently diagnosed with cerebrospinal fluid leak (csf-l) presented with acutely worsened headache and new-onset neck and back pain for one hour.She had photophobia, chills, and worsening of pain with any flexion of the spine.She denied a history of trauma, drug use, ill contacts, or recent travel.Two months prior, she had a nasopharyngeal (np) swab of her left nare for covid-19 during which she described a "popping sensation and intense pain".Since the np swab performance, the patient had experienced waxing and waning headache, left-sided rhinorrhea, post-nasal drip, cough, and intermittent fever.After failed therapies for pneumonia and allergies, she was referred to an otolaryngologist who performed a beta-2 transferrin test on her nasal discharge, confirming a diagnosis of csf-l.After rigid nasal endoscopy was unrevealing for a source, magnetic resonance imaging (mri) of the brain without intravenous contrast, coronal slice revealed small bilateral protrusions of cerebrospinal fluid below the level of the cribiform plate in the olfactory recess area of the nasal cavities bilaterally just ventral to the superior turbinates, left (arrow) slightly larger than right.She was scheduled for surgical repair and given appropriate return precautions that led her to present when she developed acutely worsened symptoms.On ed presentation, the patient was afebrile, although mildly tachycardic.With the exception of meningismus, her exam, including neurologic exam, was normal.Her white blood cell count was 19x 10e3 cells/mcl (reference range: 4.1-10.7 x 10e3 cells/mcl) with a neutrophilic predominance.She was given intravenous (iv) dexamethasone, cefepime and vancomycin, and lumbar puncture was performed.The laboratory analysis revealed cloudy fluid, a glucose level of less than 10 milligrams per deciliter (mg/dl) (reference range: 40-70 mg/dl), protein level of 732 mg/dl (reference range: 15-45 mg/dl), and nucleated cell count of 2764/mcl (reference range: 0-5 cells/ml) with 87 percent segmented neutrophils.The csf gram stain revealed gram-positive cocci, and csf culture grew streptococcus salivarius.While awaiting admission, the patient developed a mild encephalopathy, which resolved over the subsequent 24 hours with continued antibiotic therapy.During her hospitalization, the patient underwent bilateral endoscopic ethmoid repair with lumbar drain placement.Her hospital course was complicated by post-repair re-leak and development of ventriculitis.She had a ventriculostomy placed for treatment with a short course of intrathecal antibiotics in addition to a prolonged course of iv antibiotics.Once her csf studies cleared, she underwent ventriculo-peritoneal shunt placement.Her clinical status improved, and she was ultimately discharged home with minimal neurologic sequelae.Authors' comment: the case demonstrates the presence of an uncommon congenital anomaly that suffered injury during testing for covid-19, complicated further by a secondary infection resulting in bacterial meningitis.Although such anomalies are rare, the drastic increase in the performance of nasopharyngeal swabs during the covid-19 pandemic created an increased risk of iatrogenic injury and associated complication.Emergency physicians and other front-line providers should be aware of symptoms concerning for a cerebrospinal fluid leak following np swab, as early identification and surgical intervention may help avoid serious complications.Literature citations: allen b, holmes a.Case report: an intracranial complication of covid-19 nasopharyngeal swab.Clin pract cases emerg med.2021 aug;v(3):341-4.The citation of this literature article was found in table 1 of the master literature article received on 10-apr-2023 with the following citation: literature citation: pandit as, vasilica am, reka a, mallon d, toma ak, marcus hj.Covid-19 nasopharyngeal swab and cribriform fracture.Ann r coll surg engl.2023:1-6.Company comment: a 54-year-old female patient developed csf leak (cerebrospinal fluid leakage), acute streptococcal meningitis (meningitis streptococcal), ruptured congenital meningocele (meningocele) and mild encephalopathy (encephalopathy) post nasopharyngeal swab test for covid-19.In response to the event, patient was hospitalized.She underwent ventriculo-peritoneal shunt placement and her clinical status improved, and she was ultimately discharged with minimal neurologic sequelae.Considering the case information, the role of nasopharyngeal swab cannot be ruled out and the causality of cerebrospinal fluid leakage, meningitis streptococcal, meningocele and encephalopathy is assessed as possible.The case is considered serious due to medical significance of all the events which led to hospitalization of the patient and need of intervention.Cerebrospinal fluid leakage, meningitis streptococcal, meningocele and encephalopathy 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 08540
MDR Report Key16796237
MDR Text Key313834438
Report Number3015145560-2023-00001
Device Sequence Number1
Product Code KXG
Combination Product (y/n)N
Reporter Country CodeUS
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
Report Date 04/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/10/2023
Patient Sequence Number1
Treatment
APIXABAN.
Patient Outcome(s) Other; Hospitalization;
Patient Age54 YR
Patient SexFemale
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