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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC, INC. SMARK-EVIVA BREAST BIOPSY MARKER

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HOLOGIC, INC. SMARK-EVIVA BREAST BIOPSY MARKER Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Pain (1994)
Event Type  Injury  
Manufacturer Narrative
The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed. If additional relevant information is received or device evaluation completed, a supplemental medwatch will be filed. Device history record (dhr) review was unable to be conducted for the disposable device as the lot number was not provided by the complainant. (b)(4).
 
Event Description
It was reported a physician performed an eviva breast biopsy on (b)(6) 2015 and the patient was discharged home. Approximately, six months later the patient complained of "pain at the site" and the patient developed "density around the marker. " intervention was not required.
 
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Brand NameSMARK-EVIVA
Type of DeviceBREAST BIOPSY MARKER
Manufacturer (Section D)
HOLOGIC, INC.
250 campus drive
marlborough MA 01752
Manufacturer Contact
craig callahan
250 campus drive
marlborough, MA 
5082638859
MDR Report Key5464270
MDR Text Key39195926
Report Number1222780-2016-00044
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062528
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Radiologic Technologist
Type of Report Initial,Followup
Report Date 01/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/11/2016
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?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/26/2016 Patient Sequence Number: 1
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