MAUDE Adverse Event Report: HOLOGIC BIOZORB MARKER; MARKER, RADIOGRAPHIC, IMPLANTABLE

Device Problem Chemical Problem (2893)

Patient Problems Pain (1994); Anxiety (2328)

Event Date 01/28/2019

Event Type  Injury  

Event Description

My doctor placed a "biozorb marker" in my left breast after breast cancer surgery, without my knowledge or approval.It was supposed to help with radiation but my rad doc said it was not necessary at all.It is a constant source of pain and anxiety.It sends pain through my back and all the way through my breast if i hit it or bump it.It was supposed to dissolve over 12 months but i am a year and 3 months out and it has not changed.I want it out but my doctor tells me it will cause more problems if i have it removed.I absolutely hate this thing and wished i had been asked before placing this garbage in my body.Shame on the makers of this product for giving cancer patients one more problem to deal with; focal rx inc.Fda safety report id# (b)(4).

• Brand Name: BIOZORB MARKER
• Type of Device: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): HOLOGIC
• MDR Report Key: 9915593
• MDR Text Key: 186308443
• Report Number: MW5094013
• 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: 03/31/2020

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?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/01/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 50 YR
• Patient Weight: 50