MAUDE Adverse Event Report: HOLOGIC, INC. BIOZORB; MARKER, RADIOGRAPHIC, IMPLANTABLE

Health Effect - Clinical Codes	Hematoma (1884); Pain (1994)
Date of Event	03/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Severe pain a few days after initial op.At post op (a week after surgery) a hematoma started to develop in office, was drained and started again so was admitted for emergency surgery where they found that the biozorb had broken in half and likely was stabbing me internally and caused the hematoma.

• Brand Name: BIOZORB
• Common Device Name: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): HOLOGIC, INC.
• MDR Report Key: 18897845
• Report Number: MW5152791
• Device Sequence Number: 18369875
• Product Code: NEU
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/12/2024
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Race: White