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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEALTH BEACONS, INC. RFID LOCALIZER BAG MARKER, RADIOGRAPHIC, IMPLANTABLE

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HEALTH BEACONS, INC. RFID LOCALIZER BAG MARKER, RADIOGRAPHIC, IMPLANTABLE Back to Search Results
Device Problem Failure to Fire (2610)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/05/2020
Event Type  Injury  
Event Description
Breast localization device - tag (rfid) would not 'fire' or detect when stimulated; hologic. Fda safety report id# (b)(4).
 
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Brand NameRFID LOCALIZER BAG
Type of DeviceMARKER, RADIOGRAPHIC, IMPLANTABLE
Manufacturer (Section D)
HEALTH BEACONS, INC.
MDR Report Key9744646
MDR Text Key180850112
Report NumberMW5093208
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/12/2020
Is the Reporter a Health Professional? 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? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/21/2020 Patient Sequence Number: 1
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