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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN BREAST MARKER MARKER, RADIOGRAPHIC, IMPLANTABLE

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UNKNOWN BREAST MARKER MARKER, RADIOGRAPHIC, IMPLANTABLE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Arthritis (1723); Hair Loss (1877); Hypersensitivity/Allergic reaction (1907); Urticaria (2278)
Event Date 02/21/2017
Event Type  Injury  
Event Description
I had a titanium breast clip inserted into a lump. It was benign so i never had it removed. Extreme pain started within a week, angioedema and hives and hair loss started within 6 months. No dr could determine what was wrong and diagnosed arthritis and chronic idiopathic urticaria. I started xolair injections and pain management. I finally discovered i was allergic to titanium and had a lumpectomy (b)(6) 2019. All symptoms are gone and i finally feel alive again. I have exact dates and medical records to show my claim. I am concerned that these clips are general practice and i wonder how many other women are suffering. I have switched to titanium free toothpaste and no longer have sensitive teeth and i switched to titanium free sunscreen, makeup and soap and no long break out in the sun! fda safety report id # (b)(4).
 
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Brand NameBREAST MARKER
Type of DeviceMARKER, RADIOGRAPHIC, IMPLANTABLE
Manufacturer (Section D)
UNKNOWN
unknown
unknown
MDR Report Key10379168
MDR Text Key202365321
Report NumberMW5095954
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 Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 08/06/2020 Patient Sequence Number: 1
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