MAUDE Adverse Event Report: RED MEDICAL SUPPLIES: MEDIUM VISCOSITY ULTRASOUND GEL MULTI-PURPOSE BLUE COLOR; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Lot Number B030

Device Problem Nonstandard Device (1420)

Patient Problem Bacterial Infection (1735)

Event Date 08/04/2021

Event Type  malfunction  

Event Description

Received an email from (b)(6) stating there was a recall due to bacteria found in product.Red medical supplies.

• Brand Name: RED MEDICAL SUPPLIES: MEDIUM VISCOSITY ULTRASOUND GEL MULTI-PURPOSE BLUE COLOR
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• MDR Report Key: 12301580
• MDR Text Key: 266162679
• Report Number: MW5103126
• 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
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/30/2024
• Device Lot Number: B030
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 91