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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMÉRIEUX, INC. VIRTUO, A UNIT

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BIOMÉRIEUX, INC. VIRTUO, A UNIT Back to Search Results
Model Number 411660
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
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Brand NameVIRTUO, A UNIT
Type of DeviceVIRTUO, A UNIT
Manufacturer (Section D)
BIOMÉRIEUX, INC.
595 anglum road
hazelwood MO 63042
Manufacturer (Section G)
BIOMÉRIEUX, INC.
595 anglum road
hazelwood MO 63042
Manufacturer Contact
céline strauel
5, rue des aqueducs
craponne 69290
FR   69290
MDR Report Key15233983
Report Number1950204-2022-00025
Device Sequence Number1
Product Code MDB
UDI-Device Identifier03573026369767
UDI-Public03573026369767
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K161816
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/05/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/16/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number411660
Device Catalogue Number411660
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/13/2022
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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