BIOZORB

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-22 for BIOZORB manufactured by Focal Therapeutics.

Event Text Entries

[176373771] I had a lumpectomy for breast cancer on (b)(6) 2019. The surgeon implanted a? Biozorb?. The location of the biozorb is at the bottom of my armpit and is painful because it gets pushed against my ribs by my arm. While the biozorb is definitely getting smaller, if i had known that it would be painful and irritating for this long, i never would? Ve allowed the surgeon to put it in me. Also, the excuse for inserting the biozorb was so the following radiation treatment could target the tumor area. However, because i am small chested, the radiation oncologist was unable to utilize this feature due to the potential scarring a radiation boost would cause. So there was actually no reason for this device to be used on me. I also have been suffering with axillary web syndrome, which has been being treated since (b)(6) of 2019. But the? Cording? Continues to be troublesome and seems to run right through the tumor bed. The physical therapist suspects that the biozorb is causing the cording to continue to be an issue. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5092434
• MDR Report Key: 9622103
• Date Received: 2020-01-22
• Date of Report: 2020-01-19
• Date of Event: 2019-04-18
• Date Added to Maude: 2020-01-23
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BIOZORB
• Generic Name: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Product Code: NEU
• Date Received: 2020-01-22
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: FOCAL THERAPEUTICS

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	2020-01-22