MAUDE Adverse Event Report: FOCAL THERAPUTICS BIOZORB MARKER; MARKER, RADIOGRAPHIC, IMPANTABLE

Model Number F0304

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

Patient Problem Tissue Breakdown (2681)

Event Date 07/25/2019

Event Type  Injury  

Event Description

Delayed wound complication of the breast, consisting of skin breakdown at the surgical/radiation site overlying a biozorb marker.Surgical management was required for wound debridement and removal of the remaining elements of the bioabsorbable marker.

• Brand Name: BIOZORB MARKER
• Type of Device: MARKER, RADIOGRAPHIC, IMPANTABLE
• Manufacturer (Section D): FOCAL THERAPUTICS; sunnyvale CA
• Manufacturer Contact: george marcel ; 1010 stewart drive; sunnyvale, CA 94085 ; 4089627003
• MDR Report Key: 8918564
• MDR Text Key: 157761960
• Report Number: 3009718212-2019-00001
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: F0304
• Device Lot Number: PENDING
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 83 YR
• Patient Weight: 63