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

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).

• Brand Name: BREAST MARKER
• Type of Device: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): UNKNOWN; unknown; unknown
• MDR Report Key: 10379168
• MDR Text Key: 202365321
• Report Number: MW5095954
• Device Sequence Number: 1
• Product Code: NEU
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/06/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Disability
• Patient Age: 43 YR
• Patient Weight: 73