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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC, INC TRIMARK; BIOPSY SITE TISSUE MARKER DEVICE     

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HOLOGIC, INC TRIMARK; BIOPSY SITE TISSUE MARKER DEVICE      Back to Search Results
Model Number TRIMARK TD 3609
Device Problem Component Missing (2306)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/15/2019
Event Type  malfunction  
Manufacturer Narrative
The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed.If the device is returned and evaluation completed, a supplemental medwatch will be filed.Internal reference #: (b)(4).
 
Event Description
It was reported that after deploying the marker, there was no clip seen on post biopsy images.The marker could not be found anywhere.It is assumed that there was no marker inside the device.No patient injury reported.
 
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Brand Name
TRIMARK
Type of Device
BIOPSY SITE TISSUE MARKER DEVICE     
Manufacturer (Section D)
HOLOGIC, INC
250 campus drive
marlborough MA 01752
Manufacturer Contact
kelsea lyver
250 campus drive
marlborough, MA 01752
5082636130
MDR Report Key8855641
MDR Text Key155556075
Report Number1222780-2019-00176
Device Sequence Number1
Product Code NEU
UDI-Device Identifier15420045503304
UDI-Public(01)15420045503304(10)
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K023450
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 07/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/03/2020
Device Model NumberTRIMARK TD 3609
Device Catalogue NumberTRIMARK TD 3609
Device Lot Number18E04RA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/15/2019
Initial Date FDA Received08/02/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/05/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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