• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDICHOICE / ECO-MED PHARMACEUTICALS, INC. MEDICHOICE ULTRASOUND GEL TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Bacterial Infection (1735)
Event Date 08/14/2021
Event Type  Injury  
Event Description
Developed bacteremia with burkholderia -- likely exposure to medichoice ultrasound gel.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMEDICHOICE ULTRASOUND GEL
Type of DeviceTRANSDUCER, ULTRASONIC, DIAGNOSTIC
Manufacturer (Section D)
MEDICHOICE / ECO-MED PHARMACEUTICALS, INC.
MDR Report Key12358834
MDR Text Key268051333
Report NumberMW5103418
Device Sequence Number1
Product Code ITX
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 08/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 08/23/2021 Patient Sequence Number: 1
-
-