MAUDE Adverse Event Report: FOCAL THERAPEUTICS (A HOLOGIC COMPANY) BIOZORB MARKER; MARKER, RADIOGRAPHIC, IMPLANTABLE

Model Number F0203

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Increased Sensitivity (4538)

Event Date 11/19/2020

Event Type  Injury  

Event Description

Nurse from (b)(6) hospital reports patient experiencing redness and tenderness with biozorb implantation approximately 3 weeks after surgery.Patient placed on antibiotics, but redness increased.Ultimately, the bizorb marker was removed.

• Brand Name: BIOZORB MARKER
• Type of Device: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): FOCAL THERAPEUTICS (A HOLOGIC COMPANY); sunnyvale CA
• Manufacturer Contact: kristin fornieri ; 36 & 37 apple ridge road; danbury, CT 06810 ; 2037318491
• MDR Report Key: 10984726
• MDR Text Key: 220716139
• Report Number: 3009718212-2020-00003
• Device Sequence Number: 1
• Product Code: NEU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143484
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: F0203
• Device Lot Number: J2-190610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 66 YR
• Patient Weight: 49