MAUDE Adverse Event Report: HSV 2 VAGINAL PCR SWAB; HERPES SIMPLEX VIRUS NUCLEIC ACID AMPLIFICATION ASSAY

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2024

Event Type  malfunction  

Event Description

Vaginal pcr returned with patient initially positive with hsv ii, repeat swab showed no hsv ii.Patient did not experience vesicles or any signs of outbreak with positive diagnosis.Repeat swab showed no hsv ii, same lab and same sample collection technique; vikor.

• Brand Name: HSV 2 VAGINAL PCR SWAB
• Type of Device: HERPES SIMPLEX VIRUS NUCLEIC ACID AMPLIFICATION ASSAY
• MDR Report Key: 18667954
• MDR Text Key: 335071622
• Report Number: MW5151179
• Device Sequence Number: 1
• Product Code: OQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White