MAUDE Adverse Event Report: FOCAL THERAPEUTICS BIOZORB; MARKER, RADIOGRAPHIC, IMPLANTABLE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Granuloma (1876); Inflammation (1932); Pain (1994); Discomfort (2330)

Event Date 06/01/2018

Event Type  Injury  

Event Description

On march 5th i had a lumpectomy performed on my right breast.The surgeon implanted a device called biozorb.It was very uncomfortable and painful.At around 12 weeks after surgery i was due to start radiation therapy but my breast started to turn red and then a lump protruded and the area turned purple.It felt like there were bugs crawling around under my skin.My doctor was out of town so i had to go the emergency room.I was prescribed some antibiotics, my radiologist when he saw it prescribed me a different antibiotic and then after sending photos to my surgeon she prescribed a third antibiotic.Then i developed retraction of the skin and deviation of the nipple.I had to have a needle aspiration to see if it was a hematoma but that was negative.Finally, the surgeon recommended removing the biozorb device.I opted to have a complete mastectomy as i didn¿t like the way my breast was now deformed and the radiation would maybe make it worse.As soon as the breast tissue and biozorb device was removed my skin returned to a normal color and pain free.The pathology of the breast tissue showed the presence of granulomatous inflammation, foreign body type, multiple multinucleated foreign body type giant cells.This device was pushed on me and made to sound very safe and that it would help with the cosmetic appearance of my breast after the lumpectomy.I wish i had just had the breast removed and done with.I have been under treatment for 14 months and even now i have to have one last reconstruction surgery next week.

• Brand Name: BIOZORB
• Type of Device: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): FOCAL THERAPEUTICS
• MDR Report Key: 8306404
• MDR Text Key: 135685615
• Report Number: MW5083699
• 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: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 64