MAUDE Adverse Event Report: ECO-MED PHARMACEUTICALS, INC. MEDICHOICE M500812 GEL; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Device Problem Contamination (1120)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Description

The use of the medichoice m500812 gel when locating a vein for iv placement/blood drawers and associated with + blood cultures for b.Cepacia upon admission to the hospital and patient was not septic.+blood cultures + for b.Cepacia considered to be contaminating.Included in the fda recall were b029, b030, b031, b032, b040, b041, b048, b055.Fda safety report id # (b)(4).

• Brand Name: MEDICHOICE M500812 GEL
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): ECO-MED PHARMACEUTICALS, INC.
• MDR Report Key: 12313653
• MDR Text Key: 267648779
• Report Number: MW5103213
• Device Sequence Number: 1
• Product Code: ITX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1