MAUDE Adverse Event Report: UNKNOWN CONTINUOUS POSITIVE AIRWAY PRESSURE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Patient Problems Pain (1994); Rash (2033); Viral Infection (2248)

Event Date 06/01/2023

Event Type  Injury  

Event Description

I contracted hsv1 (herpes simplex virus i) (b)(6) 2010.Not an issue.Very few outbreaks in 13 years.Always kept the medication valacyclovir filled at cvs but rarely had to use.Around (b)(6) 2023, i had an hsv sore appear on my nose and my eye.I took the valacyclovir medication as usual.However, i noticed the hsv began to spread more over my nose.My cpap machine caused the virus to spread up inside of my nose as well.I contacted my doctor increased my dosage for an outbreak and the hsv continued to worsen and worsen despite taking the medication.It spread more and more from my face to the rest of my body.The sores were small, not fluid filled but seemed just under the surface.Decreased pain from the medication but 10 times more easily spread.What doesn't turn into a sore is a rash that doesn't fully develop into the sores.The rash spreads worse than the sores.Highly contagious.This medication is a different design from the medication in 2021 and prior.This is keeping the virus constantly active.Water from the shower.Sweating makes it 10 times worse and spread.10 months later this is all over my body and no letting up in sight.This has been a complete horror experience! this has destroyed my quality of life!.

• Brand Name: CONTINUOUS POSITIVE AIRWAY PRESSURE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 19078804
• MDR Text Key: 339945321
• Report Number: MW5153678
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/09/2024
• Patient Sequence Number: 1
• Treatment: LYSINE. ; SUPER B COMPLEX.; SYNTHROID 88MG.; TUROSEMIDE 10MG. ; VALACYCLOVIR.; VITAMIN A.
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 135 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White