MAUDE Adverse Event Report: ECO-MED PHARMACEUTICALS, INC. MEDIUM VISCOSITY ULTRASOUND GEL; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Lot Number C014

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

Patient Problems Unspecified Infection (1930); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/01/2021

Event Type  Injury  

Event Description

I had a cavity filled, took antibiotics but went septic within days.No one could figure out why it was so bad and happened so quickly.I was pregnant and ended up needing 2000mg of clindamycin a day to fight the infection.And tooth pain blocker at the emergency room.Then a few months later i delivered a couple weeks early because of a partial placenta abruption which again no one had s good reason as to what happened.I have had 6 previous children and my kids always come late so this was completely unexpected and out of my norm.Now i'm wondering if the ultrasound gel that was recalled, which i used a lot with my at home fetal doppler, had anything to do with it because sepsis was apparently a problem.Red medical supplies.Reason for use: ultrasound gel.On the belly with a fetal doppler.

• Brand Name: MEDIUM VISCOSITY ULTRASOUND GEL
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): ECO-MED PHARMACEUTICALS, INC.
• MDR Report Key: 12474826
• MDR Text Key: 271674041
• Report Number: MW5103922
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial

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
• Device Operator: No Information
• Device Expiration Date: 08/12/2023
• Device Lot Number: C014
• 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): Other; Required Intervention
• Patient Age: 34 YR
• Patient Weight: 63