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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDICHOICE ULTRASOUND GEL TRANSDUCER, ULTRASONIC, DIAGNOSTIC

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MEDICHOICE ULTRASOUND GEL TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Lot Number B048
Device Problem Microbial Contamination of Device (2303)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/28/2021
Event Type  malfunction  
Event Description
An unopened medichoice ultrasound gel was cultured and returned positive for burkholderia cepacia. Lot # b048. Distributed by (b)(4).
 
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Brand NameMEDICHOICE ULTRASOUND GEL
Type of DeviceTRANSDUCER, ULTRASONIC, DIAGNOSTIC
MDR Report Key12261337
MDR Text Key264946785
Report NumberMW5102925
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 07/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot NumberB048
Was Device Available for Evaluation? No Answer Provided
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

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