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U.S. Department of Health and Human Services

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

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HSV 2 VAGINAL PCR SWAB; HERPES SIMPLEX VIRUS NUCLEIC ACID AMPLIFICATION ASSAY Back to Search Results
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.
 
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Brand Name
HSV 2 VAGINAL PCR SWAB
Type of Device
HERPES SIMPLEX VIRUS NUCLEIC ACID AMPLIFICATION ASSAY
MDR Report Key18667954
MDR Text Key335071622
Report NumberMW5151179
Device Sequence Number1
Product Code OQO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Manufacturer12/21/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/07/2024
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age57 YR
Patient SexFemale
Patient EthnicityNon Hispanic
Patient RaceWhite
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