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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS, INC. MAMMOTOME MARKER (BIOPSY SITE IDENTIFIER) MARKER, RADIOGRAPHIC, IMPLANTABLE

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DEVICOR MEDICAL PRODUCTS, INC. MAMMOTOME MARKER (BIOPSY SITE IDENTIFIER) MARKER, RADIOGRAPHIC, IMPLANTABLE Back to Search Results
Catalog Number MAM3014
Device Problem Activation Problem (4042)
Patient Problem Insufficient Information (4580)
Event Date 07/23/2021
Event Type  malfunction  
Event Description
Patient presented for ultrasound guided right breast lesion and left breast 2 lesions biopsy. Post mammography was done and it does not demonstrate marker (mammotome bowtie shape) to left breast medial 9:00 position, indicating the marker did not deploy as per physician. Fda safety report id# (b)(4).
 
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Brand NameMAMMOTOME MARKER (BIOPSY SITE IDENTIFIER)
Type of DeviceMARKER, RADIOGRAPHIC, IMPLANTABLE
Manufacturer (Section D)
DEVICOR MEDICAL PRODUCTS, INC.
MDR Report Key12331617
MDR Text Key267171353
Report NumberMW5103281
Device Sequence Number1
Product Code NEU
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 08/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberMAM3014
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
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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