MAUDE Adverse Event Report: RED MEDICAL SUPPLIES, LTD / ECO-MED PHARMACEUTICALS, INC. RED MEDICAL ULTRASOUND GEL BLUE; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Device Problems Nonstandard Device (1420); Patient Device Interaction Problem (4001)

Patient Problems Unspecified Infection (1930); Scar Tissue (2060); Seroma (2069)

Event Date 05/01/2021

Event Type  Injury  

Event Description

Recalled red medical ultrasound gel blue, by red medical supplies ltd caused infected seroma requiring antibiotics for over 24 days plus three aspirations and now plastic surgeon consult for scarring, long term cortisone therapy and surgical intervention.The company will not allow refund of recalled infected product that caused the infection.Company website is difficult for nurses and patient to navigate and hours awaiting on the phone.Emails to resource on recall website are not being returned.Fda safety report id# (b)(4).

• Brand Name: RED MEDICAL ULTRASOUND GEL BLUE
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): RED MEDICAL SUPPLIES, LTD / ECO-MED PHARMACEUTICALS, INC.
• MDR Report Key: 12307399
• MDR Text Key: 266234148
• Report Number: MW5103148
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 45