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

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.

• Brand Name: SMARK-EVIVA
• Type of Device: BREAST 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 Key: 5464270
• MDR Text Key: 39195926
• Report Number: 1222780-2016-00044
• Device Sequence Number: 1
• Product Code: NEU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062528
• Number of Events Reported: 1
• 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 Received: 02/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other