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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMÉRIEUX, INC. CONTROL MODULE PKGD 3D

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BIOMÉRIEUX, INC. CONTROL MODULE PKGD 3D Back to Search Results
Model Number 210147
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
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Brand NameCONTROL MODULE PKGD 3D
Type of DeviceCONTROL MODULE PKGD 3D
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 Key15234101
Report Number1950204-2022-00026
Device Sequence Number1
Product Code MDB
UDI-Device Identifier03573026049522
UDI-Public03573026049522
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K903505
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 10/27/2022
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 Model Number210147
Device Catalogue Number210147
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/20/2022
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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