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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOPSY CLIPS

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BIOPSY CLIPS Back to Search Results
Device Problem Migration or Expulsion of Device (1395)
Patient Problem Discomfort (2330)
Event Type  Other  
Event Description
My complaint involves biopsy clips placed in the breast after a biopsy mammogram procedure. These clips are placed to locate the area if further findings appear. I have two placed in my right breast upper and lateral positions. After a follow-up exam, only the upper clip viewed. The second couldn't be found. The purpose of the clips, explained to me would make it easier to detect the biopsied area. Since then, no other findings have appeared and i've requested removal of these clips following the procedure due to discomfort. I thought the clips were routine. Procedure done (b)(6) 2014, women's imaging at mercy. I consented to this procedure on my doctor's advise and after speaking with a family member and friend who had biopsies, no clips were used or mentioned. I've consulted two surgeons on removal. They say it's possible causing discomfort scar tissue due to the procedure and the third refused because of liability. Surgeons refused removal also. The ultrasound guided biopsy was recommended by the first doctor i saw, but after canceling that appointment, i rescheduled and received a different doctor who did the stereotactic biopsy rather than the ultrasound. I've complained about discomfort since the procedure. I was told to give it time, which i did, followed-up on exams, nothing has changed. When i spoke with the doctor to remove these clips, she said i don't mean to be condescending, but if you've had any surgery you have metal in your body anyway and besides a surgeon isn't going to remove it anyway. I asked why not? because they are not going to remove it from a healthy body, was her reply. Only a surgeon could remove them, but a surgeon didn't do the procedure. She did a radiologist. Legally this doesn't qualify as malpractice according to laws firms i've spoken to. I would appreciate your advise regarding this matter.
 
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Brand NameBIOPSY CLIPS
Type of DeviceBIOPSY CLIPS
MDR Report Key5522312
MDR Text Key41224864
Report NumberMW5061237
Device Sequence Number1
Product Code NEU
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/15/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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