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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC, INC. TRIMARK MARKER, RADIOGRAPHIC, IMPLANTABLE

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HOLOGIC, INC. TRIMARK MARKER, RADIOGRAPHIC, IMPLANTABLE Back to Search Results
Catalog Number TRIMARK-EVIVA-2S-10
Device Problem Detachment Of Device Component (1104)
Patient Problem Foreign Body In Patient (2687)
Event Date 02/09/2017
Event Type  malfunction  
Event Description
Breast biopsy site marker clip (stereo) was used during stereotactic biopsy procedure. During stereo, clip was seen on image. Deployment device was withdrawn, patient taken to mammography room for post procedure image, and clip was not seen on image.
 
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Brand NameTRIMARK
Type of DeviceMARKER, RADIOGRAPHIC, IMPLANTABLE
Manufacturer (Section D)
HOLOGIC, INC.
250 campus dr.
marlborough MA 01752
MDR Report Key6449121
MDR Text Key71375958
Report Number6449121
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 03/24/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/31/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/20/2018
Device Catalogue NumberTRIMARK-EVIVA-2S-10
Device Lot Number16H20RF
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/24/2017
Event Location Hospital
Date Report to Manufacturer03/24/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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