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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 Name
MEDICHOICE ULTRASOUND GEL
Type of Device
TRANSDUCER, 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
1 Patient was 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 No Information
Device Lot NumberB048
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
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