BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOZORB

    MDR report key: 22967556 · Received September 4, 2025

    Report

    Report Number
    MW5175639
    Event Type
    Injury
    Date Received
    September 4, 2025
    Date of Event
    June 10, 2019
    Report Date
    August 29, 2025
    Manufacturer
    HOLOGIC, INC.
    Product Code
    NEU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    BIOZORB 3X3X1 CM. LOT K1-181015. EXPIRATION DATE MARCH 31, 2021 PLACED DURING LUMPECTOMY SURGERY. PATIENT HAS HAD CONTINUED PAIN AT AND AROUND INSERTION LOCATION AND INFECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1975395 BIOZORB MARKER, RADIOGRAPHIC, IMPLANTABLE NEU HOLOGIC, INC. K1-181015

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Disability CASCARA SAGRADA.| FISH OIL.| LEVOTHYROXINE.| LYCOPENE.| MAGNESIUM.| MELATONIN.| NALTREXONE.| SENNA.| SERUM EYE DROPS.| VITAMIN C.| VITAMIN D.