FDA Adverse Event Injury Summary report: N

BIOZORB

MDR report key: 20610982 · Received November 4, 2024

Report

Report Number
MW5162155
Event Type
Injury
Date Received
November 4, 2024
Date of Event
August 17, 2023
Report Date
October 30, 2024
Manufacturer
HOLOGIC, INC.
Product Code
NEU
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NM, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

MY PRIMARY CARE DOCTOR ALLOWED A LICENSED RADIOLOGIST, (B)(6), MD AT THE (B)(6). PERMISSION TO IMPLANT A HOLOGICS BIOZORB CLIP DESIGNED TO LOCATE A SITE FOR A LATER RADIATION PROCEDURE, MY PERMISSION WAS NOT REQUESTED NOR OBTAINED FOR THIS PROCEDURE, WHICH WAS NOT PERFORMED BY DR. (B)(6) BUT A NURSE NAMED "(B)(6)" WORKING AT THE (B)(6). THERE WAS A REPORT SIGNED BY DR (B)(6) CLAIMING TO HAVE PERFORMED THE BIOPSY, BUT WAS NOT DONE BY (B)(6), AND FROM THE DAY OF THAT PROCEDURE TO THE DAY OF THE SURGERY TO REMOVE THE CLIP FROM MY BREAST, (B)(6) 2024, I EXPERIENCED " NERVE PAIN" IN MY LEFT BREAST. IN SPITE OF DENIAL OF A METAL CLIP IN MY LEFT BREAST, A SCAN OF THAT BREAST SHOWED PRESENT METAL CLIP ONLY FOUND IN BIOZORB METAL CLIP AS DESCRIBED BY (B)(6) OF MEDICAL RECORDS AS MADE BY HOLOGICS! THEY DENIED ANY METAL IN MY BREAST UNTIL I TOOK PROOF TO THE HEAD OF THE MEDICAL RECORDS AND WAS ABLE TO ASSURE THEM THAT THE SIGNATURE ON MY PAPERWORK HAD BEEN MOVED FROM ANOTHER SIGN- IN RELEASE FROM MONTHS BEFORE THIS PROCEDURE! I WAS ASKED TO REPORT THIS DECEPTION AND SAID I WOULD AFTER THIS REPORT WAS ENTERED. I HAVE NOT MADE AN APPOINTMENT WITH THE STATES ATTORNEY GENERAL WHO IS ASKING FOR OTHER "COVER-UPS" ABC HAS COVERED WITH (B)(6) OVER OTHER CASES! THE TISSUE HAS BEEN SAVED BY MY SURGEON AND I AM JOINING A CLASS ACTION LAWSUIT WITH ATTORNEYS IN (B)(6)! MY NAME IS (B)(6) AND MY DATE OF BIRTH IS: (B)(6) 1939. WHEN I MADE A COMPLAINT I WAS TOLD IT WAS "RESOLVED" & FOUND OUT THE CFO HAD RESIGNED FROM (B)(6)! PLEASE HELP ME GET JUSTICE FOR THE SUFFERING I ENDURED AT THE HANDS OF THESE MALPRACTICE PROFESSIONALS! MY PHONE # IS (B)(6). I DO NOT MEASURE TESTING, WILL COPY OPERATING NOTES FROM DR (B)(6) AT (B)(6) IN (B)(6).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1460699 BIOZORB MARKER, RADIOGRAPHIC, IMPLANTABLE NEU HOLOGIC, INC.

Patients

Seq Age Sex Outcome Treatment
1 84 YR Female Hospitalization| O| R BENZEDREX NASAL DECONGESTANT.| CARTIA XT 180/24 HR CAP.| FUROSEMIDE 40MG.| GABAPENTIN 60MG.| NASAL SPRAY 50MCG| NATROL COGNIUM COMPLETE.| SINGULAR 40MG.| SPIRONOLACTONE 50MG| SYNTHROID 100MI.| VITAMIN D3 1000 IU. | WELLBUTRIN 300XL.| XARELTO 15 MG DC.