MAUDE Adverse Event Report: RED ULTRASOUND GEL FOR FETAL DOPPLER; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/26/2021

Event Type  Injury  

Event Description

I had been using the gel for at home doppler use and on (b)(6) 2012 i had a miscarriage after going to the hospital two previous times where they just told me to take the antibiotics.There was some type of infection in my body but they couldn't figure out, why.

• Brand Name: RED ULTRASOUND GEL FOR FETAL DOPPLER
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• MDR Report Key: 12294510
• MDR Text Key: 265984130
• Report Number: MW5103101
• Device Sequence Number: 1
• Product Code: IYO
• 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: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other
• Patient Age: 27 YR
• Patient Weight: 147