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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); Head Injury (1879)
Event Type  Injury  
Event Description
This literature case, derived from an abstract, was received on 29-mar-2022.It described a 54-year-old female patient who developed "skull base injury" (pt: skull trauma) post nasopharyngeal swab test for covid-19.Case report: a 54-year-old woman presenting with persistent colourless nasal discharge for 2 weeks following a traumatic covid-19 nasopharyngeal swab.A beta 2-transferrin test confirmed cerebrospinal fluid (csf) rhinorrhoea and a high-resolution sinus computed tomography (ct) scan demonstrated a cribriform plate defect.Magnetic resonance imaging showed radiological features of ): a yuh grade v empty sella and thinned anterior skull base.24-hour intracranial pressure (icp) monitoring confirmed raised pressures, prompting insertion of a ventriculoperitoneal shunt.The patient underwent ct cisternography and endoscopic transnasal repair of the skull base defect using a fluorescein adjuvant, without complications.Authors' comment: the literature review suggests an underlying association between iih, csf rhinorrhoea and swab-related skull base injury.It highlighted a comprehensive management pathway for these patients, including high-resolution ct with cisternography, icp monitoring, shunt and fluorescein-based endoscopic repair to achieve the best standard of care.Literature citation: vasilica am, reka a, mallon d, toma ak, marcus hj, pandit as.Covid-19 nasopharyngeal swab and cribriform fracture.Ann r coll surg engl.2023 mar.Company comment: a 54-year-old patient developed skull base injury (skull trauma) post nasopharyngeal swab test for covid-19.She underwent insertion of a ventriculoperitoneal shunt and endoscopic transnasal repair of the skull base defect.Considering the case information, the role of nasopharyngeal swab cannot be ruled out and the causality of skull trauma is assessed as possible (confounded by underlying association between idiopathic intracranial hypertension and csf rhinorrhoea).The case is considered serious due to medical significance of event which required intervention.Skull trauma is unlisted as per uspi.
 
Event Description
This literature case, derived from an abstract, was received on 29-mar-2022.It described a 54-year-old female patient who developed "skull base injury" (pt: head injury) post nasopharyngeal swab test for covid-19.Case report: a 54-year-old woman presenting with persistent colourless nasal discharge for 2 weeks following a traumatic covid-19 nasopharyngeal swab.A beta 2-transferrin test confirmed cerebrospinal fluid (csf) rhinorrhoea and a high-resolution sinus computed tomography (ct) scan demonstrated a cribriform plate defect.Magnetic resonance imaging showed radiological features of idiopathic intracranial hypertension (iih): a yuh grade v empty sella and thinned anterior skull base.24-hour intracranial pressure (icp) monitoring confirmed raised pressures, prompting insertion of a ventriculoperitoneal shunt.The patient underwent ct cisternography and endoscopic transnasal repair of the skull base defect using a fluorescein adjuvant, without complications.Authors' comment: the literature review suggests an underlying association between iih, csf rhinorrhoea and swab-related skull base injury.It highlighted a comprehensive management pathway for these patients, including high-resolution ct with cisternography, icp monitoring, shunt, and fluorescein-based endoscopic repair to achieve the best standard of care.Literature citation: vasilica am, reka a, mallon d, toma ak, marcus hj, pandit as.Covid-19 nasopharyngeal swab and cribriform fracture.Ann r coll surg engl.2023 mar.Company comment: a 54-year-old patient developed skull base injury (head injury) post nasopharyngeal swab test for covid-19.She underwent insertion of a ventriculoperitoneal shunt and endoscopic transnasal repair of the skull base defect.Considering the case information, the role of nasopharyngeal swab cannot be ruled out and the causality of skull trauma is assessed as possible (confounded by underlying idiopathic intracranial hypertension).The case is considered serious due to medical significance of event which required intervention.Head injury is unlisted as per uspi.Additional significant information was received on 10-apr-2023 from a full-text article.An additional event "cerebrospinal fluid (csf) rhinorrhoea" (pt: cerebrospinal fluid leakage) was reported.Case report: a 54-year-old female healthcare assistant presented to the emergency department of her local hospital complaining of persistent colourless nasal discharge.Two weeks prior, the patient had undertaken a routine nasopharyngeal swab for reverse transcription polymerase chain reaction covid-19 testing, the experience of which was described as reasonably traumatic.Her past medical history included a history of non-specific chronic headaches, which she managed symptomatically, and her body mass index was above 30.Other than over-the-counter analgesics, she did not take any regular medications.On examination, she was fully orientated and demonstrated no focal neurological deficits, or any signs of trauma to the skull base.Suspecting that the nasal discharge was cerebrospinal fluid (csf) following endonasal trauma, the emergency team tested the beta 2-transferrin of the nasal fluid.This was positive, with a value of 39.50mg/l (normal: less than 1.30mg/l).A computed tomography (ct) head-sinus scan was also performed which reported an "opacification of the right intranasal olfactory recesses and disrupted integrity of the right cribriform plate".She was urgently transferred to our neurosurgical centre for further investigation and treatment.A magnetic resonance imaging (mri) head scan was performed and demonstrated a yuh grade v empty sella turcica but no other radiological signs of intracranial hypertension, namely optic nerve tortuosity or peri optic nerve sheath distension.Suspecting an underlying diagnosis of idiopathic intracranial hypertension (iih), she underwent 24-h invasive intracranial pressure (icp) monitoring, which confirmed significantly raised pressures.Three days later, a ventriculoperitoneal (vp) shunt was inserted under neuro-navigational guidance without complication.The rhinorrhoea improved but remained intermittent over the next month, worsening when she lay down.She was then readmitted for endoscopic trans nasal repair of the right cribriform plate defect.A week prior to the surgical intervention, the patient underwent a ct cisternogram and contrast tracking was noted from the right nostril.Postoperatively the patient recovered well, without further evidence of csf rhinorrhoea.Author's comment: iih appears to be independently associated with calvarial and skull base thinning, and previous studies have demonstrated the association between iih and spontaneous csf rhinorrhoea, possibly as a pathological variant.The main site of skull base trauma occurred in the ethmoid cribriform plate (86 percent), likely due to an incorrect swab trajectory.The marked adherence of the dura mater on the anterior skull base surface predisposes to post-traumatic laceration, leading to csf rhinorrhoea, an encephalocele or parenchymal contusion.The case raises important questions regarding the underlying association between iih, csf rhinorrhoea and swab-related skull base injury.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 mar:1-6.Company comment: a 54-year-old patient developed skull base injury (head injury) and cerebrospinal fluid rhinorrhoea (cerebrospinal fluid leakage) post nasopharyngeal swab test for covid-19.She underwent insertion of a ventriculoperitoneal shunt and endoscopic trans nasal repair of the skull base defect.Considering the case information, the role of nasopharyngeal swab cannot be ruled out and the causality of head injury and cerebrospinal fluid leakage is assessed as possible (confounded by idiopathic intracranial hypertension).The case is considered serious due to medical significance of head injury which required intervention.Head injury and cerebrospinal fluid leakage 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 08540
MDR Report Key16710189
MDR Text Key312989269
Report Number3015145560-2022-00015
Device Sequence Number1
Product Code KXG
Combination Product (y/n)N
Reporter Country CodeGB
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/29/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/29/2023
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age54 YR
Patient SexFemale
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