BioZorb LP Marker F0231Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00851766006078), received between Sep 5, 2023 and Sep 6, 2023 — classified as 2 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT PARTIAL MASTECTOMY ON (B)(6) 2020 DURING WHICH A BIOZORB WAS IMPLANTED. PATIENT HAD A PRIOR DIAGNOSIS OF RIGHT BREAST INVASIVE LOBULAR CARCINOMA. PATIENT REPORTED SUFFERED FROM PAIN, A HARD LUMP, DEFORMITY, SCARRING , SENSITIVITY, ITCHING, SWELLING AND REDDENING OF HER SKIN, FIBROSIS, LYMPHEDEMA, SEROMA, AND EDEMA. PATIENT REPORTED IS HAVING ISSUES SLEEPING AND CAUSING DISCOMFORT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Anxiety; Breast Discomfort/Pain; Itching Sensation; Scar Tissue; Seroma; Sleep Dysfunction; Swelling/ Edema

  MAUDE report 17695483 ↗
• InjurySep 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED A BIOZORB IN (B)(6) 2022. THE PATIENT COMPLAINTS THAT SHE SUFFERS FROM A HARD PAINFUL LUMP, SENSITIVITY AND CONSTANT SWELLING OF HER BREAST. PATIENT HAS HAD TO RECEIVE PHYSICAL THERAPY DUE TO THE PAIN AND REPORTS A DEFORMITY IN HER BREAST. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 17684514 ↗