MAUDE Adverse Event Report: UNKNOWN HSV2 IGG TEST; ENZYME LINKED IMMUNOSORBENT ASSAY, HERPES SIMPLEX VIRUS, HSV-2

Patient Problem Insufficient Information (4580)

Event Date 11/21/2023

Event Type  Injury  

Event Description

False positive hsv2 serology.Second test (b)(6) 2023 result 5.03.

• Brand Name: HSV2 IGG TEST
• Type of Device: ENZYME LINKED IMMUNOSORBENT ASSAY, HERPES SIMPLEX VIRUS, HSV-2
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 18426094
• MDR Text Key: 331832991
• Report Number: MW5149708
• Device Sequence Number: 1
• Product Code: MYF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White