MAUDE Adverse Event Report: FOSUN PHARMACEUTICALS USA MEDICAL SWAB; NASOPHARYNGEAL SWAB

Device Problem Use of Device Problem (1670)

Patient Problems Cerebrospinal Fluid Leakage (1772); Skull Fracture (2077)

Event Type  Injury  

Event Description

This literature case, derived from a conference abstract, was received on 04-may-2022.It described a young female patient of unknown age who presented with a cerebrospinal fluid leak related to a traumatic skull base injury (pt: cerebrospinal fluid leakage and pt: skull fractured base) post nasopharyngeal swab test for coronavirus disease 2019 (covid-19).Case report: in this paper, the case of a young lady was reported who presented a cerebrospinal fluid leak related to a traumatic skull base injury in the immediate follows of a nasopharyngeal swab for covid-19.Author's comment: the nasal swab testing might lead to iatrogenic damages.In this paper, cerebrospinal fluid leak related to a traumatic skull base injury in the immediate follows of a nasopharyngeal swab for covid-19 was reported.Literature citation: gader g, badri m, nasri r, rkhami m, bahri k, zammel i.Cerebrospinal fluid rhinorrhea following a covid-19 nasopharyngeal swab: a case report and review of the literature.J neurol surg b skull base.2022 feb;83(suppl 1).This is a conference abstract, and no further information is available at present time.Company comment: a patient presented with a cerebrospinal fluid leak related to a traumatic skull base injury (cerebrospinal fluid leakage and skull fractured base) post nasopharyngeal swab test for coronavirus disease 2019 (covid-19).Further information regarding the events and medical history is limited.Considering the limited case information, the role of nasopharyngeal swab cannot be ruled out and the causality of skull fractured base and cerebrospinal fluid leakage is assessed as possible with nasopharyngeal swab.The case is considered serious due to medical significance of the events.Skull fractured base and cerebrospinal fluid leakage are unlisted as per uspi.

• Brand Name: MEDICAL SWAB
• Type of Device: NASOPHARYNGEAL SWAB
• Manufacturer (Section D): FOSUN PHARMACEUTICALS USA; suite 204; 104 carnegie center; princeton NJ 08540
• MDR Report Key: 14405289
• MDR Text Key: 294762285
• Report Number: 3015145560-2022-00004
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): N
• Reporter Country Code: TS
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female