MAUDE Adverse Event Report: HOLOGIC SURGICAL PRODUCTS COSTA RICA, S.R.L. BIOZORB; MARKER, RADIOGRAPHIC, IMPLANTABLE

Device Problems Improper or Incorrect Procedure or Method (2017); Patient Device Interaction Problem (4001)

Patient Problems Breast Mass (2439); Breast Discomfort/Pain (4504)

Event Date 07/27/2018

Event Type  Injury  

Event Description

I underwent a lumpectomy for a malignant breast tumor.Prior to surgery biozorb was discussed and i told dr i did not want a biozorb placed in me.Day of surgery surgeon has a problem finding the tumor and excised excessive amount of tissue while attempting to find it.Surgeon then placed a biozorb in me to fill the void created by excising too much tissue.Biozorb was very painful, my skin pulled in around it, and then had to be removed on (b)(6) 2018.I still have pain in the area were the biozorb was.Breast implants post biozorb removal.Fda safety report id#: (b)(4).

• Brand Name: BIOZORB
• Type of Device: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): HOLOGIC SURGICAL PRODUCTS COSTA RICA, S.R.L.
• MDR Report Key: 11640783
• MDR Text Key: 244868118
• Report Number: MW5100665
• Device Sequence Number: 1
• Product Code: NEU
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 56 YR