MAUDE Adverse Event Report: BLUE ULTRASOUND COUPLANT TRANSMISSION FETAL DOPPLER GEL; MEDIA, COUPLING, ULTRASOUND

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Unspecified Infection (1930); Itching Sensation (1943); Tissue Breakdown (2681); Skin Disorders (4543)

Event Date 05/16/2021

Event Type  Injury  

Event Description

I purchased "2 bottles of blue ultrasound gel for my fetal doppler" back in (b)(6) 2021 and used it often.On (b)(6) 2021, i noticed my skin was becoming terribly itchy and open sores which appeared infected began to show up on my arms and top of thighs.Now being (b)(6) 2021, i am now almost 8 months pregnant, and the open sores still cover most of my body.They tend to itch more frequently at night, and have resisted multiple fungal and antibacterial treatments.(b)(6) ltd.Fda safety report id # (b)(4).

• Brand Name: BLUE ULTRASOUND COUPLANT TRANSMISSION FETAL DOPPLER GEL
• Type of Device: MEDIA, COUPLING, ULTRASOUND
• MDR Report Key: 12475898
• MDR Text Key: 271849861
• Report Number: MW5103968
• Device Sequence Number: 1
• Product Code: MUI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 09/12/2021

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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/14/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 27 YR
• Patient Weight: 107