BioZorb Marker F0405Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00851766006054), received between Sep 2, 2024 and Sep 2, 2024 — 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 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 70 YEARS OLD, 51 KG FEMALE PATIENT UNDERWENT A PARTIAL MASTECTOMY ON (B)(6) 2020, EXCISION OF LYMP NODES AND PLACEMENT OF BIOZORB. DAYS AFTER THE SURGERY PATIENT CAME BACK AND HAD A SEROMA DRAINGED OF 75 ML. POSTERIORLY HER BREAST WOUND DRAINED YELLOW AND CLOUDY FLUID. BIOZORB WAS EASILY PALPATED AND PATIENT REQUIRED ANTIBIOTICS, SEVERAL ASPIRATIONS, AND THE REMOVAL OF BIOZORB ON (B)(6) 2020. BIOZORB WAS REMOVED IN 2 PIECES AND DISCARDED. PATIENT HAD A HISTORY OF HYPERTENSION. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Seroma; Wound Infection

  MAUDE report 20118335 ↗
• InjurySep 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT HAD A PARTIAL MASTECTOMY WITH BIOZORB PLACEMENT. A FEW DAYS AFTER THE SURGERY PATIENT DEVELOPED SWELLING , INCREASED TEMPERATURE , PAIN , REDNESS AND FEVER AT THE IMPLANTATION SITE. PATIENT WAS TREATED WITH ANTIBIOTICS AND A DRAIN WAS PLACED. NO OTHER INFORMATION AVAILABLE

  Patient problems: Breast Discomfort/Pain; Erythema; Fever; Post Operative Wound Infection; Swelling/ Edema

  MAUDE report 20117811 ↗