MAUDE Adverse Event Report: OWENS & MINOR DISTRIBUTION, INC. MEDICHOICE ULTRASOUND GEL; MEDIA, COUPLING, ULTRASOUND

Lot Number B030

Device Problem Nonstandard Device (1420)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Event Description

Developed bacteremia with burkholderia - likely exposure to medichoice ultrasound gel - before recall notice was issued one of seven patients at our hospital with this infection -we had the affected lot numbers of medichoice ultrasound gel.

• Brand Name: MEDICHOICE ULTRASOUND GEL
• Type of Device: MEDIA, COUPLING, ULTRASOUND
• Manufacturer (Section D): OWENS & MINOR DISTRIBUTION, INC.; 9120 lockwood boulevard; mechanicsville VA 23116
• MDR Report Key: 12342961
• MDR Text Key: 267626840
• Report Number: MW5103351
• Device Sequence Number: 1
• Product Code: MUI
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 08/17/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 72