BioZorb F0203Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 15420045513990), received between Sep 5, 2023 and Aug 26, 2025 — classified as 48 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 reports).

2 FDA recall records name this device's identifier, 2 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Oct 10, 2024Open, Classified

   Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort.

   Z-0328-2025 · Root cause: Device Design · FDA record ↗

2. Mar 13, 2024Open, Classified

   Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from feeling the device in the breast, and the need for additional medical treatment to remove the device

   Z-1733-2024 · Root cause: Unknown/Undetermined by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A BIOZORB DEVICE IMPLANT ON (B)(6) 2022. IT WAS FURTHER REPORTED THAT THE PATIENT HAS EXPERIENCED INJURIES AT AND AROUND THE SITE OF IMPLANTATION, WHICH INCLUDE CONSTANT PAIN, A HARD PAINFUL LUMP, DEFORMITY, SCARRING, SENSITIVITY, ITCHING, SWELLING, ERYTHEMA AND FAILURE TO REABSORB. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Abnormal scarring; Breast Discomfort/Pain; Breast Mass; Deformity/ Disfigurement; Erythema; Hypersensitivity/Allergic reaction; Itching Sensation

  MAUDE report 22897085 ↗
• InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A BIOZORB DEVICE IMPLANT ON AN UNKNOWN DATE. IT WAS FURTHER REPORTED THAT THE PATIENT HAS EXPERIENCED INJURIES AT AND AROUND THE SITE OF IMPLANTATION, WHICH INCLUDE PAIN, PROTRUSION FROM UNDER THE PATIENTS LEFT AXILLA, FAILURE TO REABSORB, MOBILITY ISSUES AND SLEEP DYSFUNCTION. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Erosion; Sleep Dysfunction

  MAUDE report 22839501 ↗
• InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HOLOGIC HAS RECEIVED CORRESPONDENCE ARISING FROM LITIGATION. THE ADDITIONAL MEDICAL INFORMATION PROVIDED REVEALED THE CATALOG NUMBER F0203 OF THE IMPLANTED DEVICE. ON (b)(6), 2023 AND (b)(6), 2024 THE PATIENT REQUESTED REPEATEDLY THE BIOZORB REMOVAL AND WAS ADVISED AGAINST THIS BY THE MEDICAL PROFESSIONALS. NO OTHER RELEVANT INFORMATION WAS PROVIDED.THIS REPORT IS BEING SUBMITTED PURSUANT TO 21 CFR PART 803 BASED ON INFORMATION MADE AVAILABLE TO HOLOGIC THROUGH LITIGATION. CONSISTENT WITH 21 CFR 803.16, THE SUBMISSION OF THIS REPORT IS NOT INTENDED, AND SHALL NOT BE CONSTRUED, AS AN ADMISSION, ACKNOWLEDGMENT, OR CONFIRMATION BY HOLOGIC THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

  Patient problems: Breast Discomfort/Pain; Erythema; Itching Sensation; Seroma; Swelling/ Edema

  MAUDE report 22535907 ↗
• InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HOLOGIC HAS RECEIVED CORRESPONDENCE ARISING FROM LITIGATION. THE ADDITIONAL MEDICAL INFORMATION PROVIDED, REVEALED THE F0203 CATALOG NUMBER OF THE DEVICE AND THE LOT NUMBER 21J21RY OF THE DEVICE. THE IMPLANT DATE IS NOTED IN THE MEDICAL REPORTS AS (b)(6), 2022. NO OTHER RELEVANT INFORMATION WAS PROVIDED.THIS REPORT IS BEING SUBMITTED PURSUANT TO 21 CFR PART 803 BASED ON INFORMATION MADE AVAILABLE TO HOLOGIC THROUGH LITIGATION. CONSISTENT WITH 21 CFR 803.16, THE SUBMISSION OF THIS REPORT IS NOT INTENDED, AND SHALL NOT BE CONSTRUED, AS AN ADMISSION, ACKNOWLEDGMENT, OR CONFIRMATION BY HOLOGIC THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

  Patient problems: Abscess; Bacterial Infection; Breast Discomfort/Pain; Cellulitis; Erythema

  MAUDE report 22535722 ↗
• InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HOLOGIC HAS RECEIVED CORRESPONDENCE ARISING FROM LITIGATION. THE ADDITIONAL MEDICAL INFORMATION PROVIDED, REVEALED THE F0203 CATALOG NUMBER OF THE DEVICE AND THE LOT NUMBER 21C19RX OF THE DEVICE. NO OTHER RELEVANT INFORMATION WAS PROVIDED.THIS REPORT IS BEING SUBMITTED PURSUANT TO 21 CFR PART 803 BASED ON INFORMATION MADE AVAILABLE TO HOLOGIC THROUGH LITIGATION. CONSISTENT WITH 21 CFR 803.16, THE SUBMISSION OF THIS REPORT IS NOT INTENDED, AND SHALL NOT BE CONSTRUED, AS AN ADMISSION, ACKNOWLEDGMENT, OR CONFIRMATION BY HOLOGIC THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 22535431 ↗
• InjuryJun 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, A PATIENT RECEIVED A BIOZORB DEVICE. IT IS REPORTED THAT THE PATIENT HAS EXPERIENCE INJURIES AT AND AROUND THE SITE OF IMPLANTATION, WHICH INCLUDE PAIN, A HARD LUMP, DEFORMITY, ACHES, INFLAMMATION, AND EXTREME SENSITIVITY. ADDITIONALLY, IT IS REPORTED THAT THE PATIENT IS UNABLE TO SLEEP BECAUSE OF THE PAIN AND DISCOMFORT CAUSED BY THE BIOZORB. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Breast Discomfort/Pain; Breast Mass; Deformity/ Disfigurement; Inflammation; Seroma; Sleep Dysfunction

  MAUDE report 22169035 ↗
• InjuryJun 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, A PATIENT RECEIVED A BIOZORB DEVICE. IT IS REPORTED THAT THE PATIENT HAS SUFFERED FROM INJURIES AT AND AROUND THE SITE OF IMPLANTATION, WHICH INCLUDE A HARD, PAINFUL LUMP, SWELLING, DEFORMITY, SCARRING, AND SENSITIVITY AT THE SITE OF THE BIOZORB MARKER. IT IS REPORTED THAT THE PAIN WAS WORSENED UPON CONTACT AT THE SITE OF THE BIOZORB MAKING IT DIFFICULT TO SLEEP. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Breast Discomfort/Pain; Breast Mass; Deformity/ Disfigurement; Scar Tissue; Sleep Dysfunction; Swelling/ Edema

  MAUDE report 22168898 ↗
• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A BIOZORB DEVICE ON (B)(6) 2022. PATIENT LATER REPORTED SHE SUFFERED FROM SCAR TISSUE AND SCARRING AT THE IMPLANTATION SITE, FLUID BUILDUP, RECURRING RASHES, CELLULITIS, ITCHING AND CHRONIC PAIN. PATIENT IS ACTIVELY SEEKING TREATMENT AND ANTICIPATES THE NEED FOR FUTURE SURGERY TO REMOVE THE BIOZORB BUT HASN´T REMOVED IT. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Cellulitis; Itching Sensation; Scar Tissue

  MAUDE report 21931504 ↗
• InjuryApr 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A BIOZORB DEVICE ON (B)(6) 2019, THE PATIENT REPORTED THAT AFTER IMPLANTATION SHE HAS SUFFERED FROM A HARD LUMP, STABBING PAIN, DISCOMFORT, IRRITATION, SWELLING, SLEEP DYSFUNCTION AND THE DEVICE HAS FRACTURED AND PER PATIENT MIGRATED WITHIN HER BREAST. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Sleep Dysfunction; Swelling/ Edema

  MAUDE report 21844573 ↗
• InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A BIOZORB DEVICE ON (B)(6) 2016, PATIENT REPORTED THAT SHE IS SUFFERING FROM HARD PAINFUL LUMP, DEFORMITY, SCARRING, SENSITIVITY, ITCHING, SWELLING AND REDNESS AND THE SITE OF IMPLANTATION. ADDITIONALLY PATIENT REPORTS THAT THE MARKER FAILED TO RESORB. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement; Erythema; Scar Tissue; Swelling/ Edema; Twitching

  MAUDE report 21734803 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A BIOZORB DEVICE ON (B)(6) 2018, DURING A LUMPECTOMY. THE PATIENT RECEIVED ADDITIONAL RADIATION (B)(6) 2019. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN, PALPABILITY AND NON-HEALING WOUNDS. ON (B)(6) 2019, IT WAS REPORTED THAT PATIENT HAD CHRONIC NON-HEALING WOUND AT THE SURGICAL SITE. THE BIOZORB WAS REMOVED ON AN UNKNOWN DATE, AND THE BREAST HEALED. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Impaired Healing

  MAUDE report 21678290 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A BIOZORB DEVICE ON (B)(6) 2017, DURING A LUMPECTOMY. IT WAS REPORTED THAT THE PATIENT HAD A RE-EXCISION ON (B)(6) 2019, WITH BIOZORB PLACEMENT AND PATIENT DEVELOPED LOCAL CELLULITIS AT THE SURGICAL SITE AND THE BIOZORB ERODED THROUGH THE SKIN. SEROMA WAS ASPIRATED. NO RECURRENCE. SHE WAS TAKEN TO THE OPERATING ROOM ON (B)(6) 2019, FOR REMOVAL AND DEBRIDEMENT. WOUND WAS PACKED AND DRAIN PLACED. ANTIBIOTICS WERE COMPLETED AND INFECTIOUS DISEASE AND WOUND CARE CONSULTED. PATIENT FINALLY HEALED IN (B)(6) 2019.

  Patient problems: Bacterial Infection; Seroma

  MAUDE report 21678281 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A BIOZORB MARKER ON (B)(6) 2018, DURING A LUMPECTOMY. THE PATIENT REPORTED EXPERIENCING TOO MUCH PAIN AND REDNESS IN THE AREA AND REQUESTED THE SURGEON TO REMOVE THE DEVICE. IT WAS REPORTED THAT THE DEVICE WAS REMOVED BY THE PHYSICIAN ON AN UNKNOWN DATE. NO ADDITIONAL INFORMATION.

  Patient problems: Breast Discomfort/Pain; Erythema

  MAUDE report 21678277 ↗
• InjuryMar 24, 2025Fracture; Migration; Fracture; Migration

  IT WAS REPORTED THAT A PATIENT RECEIVED A BIOZORB DURING A LUMPECTOMY ON (B)(6) 2019, DURING THIS SURGERY A SMALL HEMATOMA WAS REPORTED AS COMPLICATION. ON (B)(6) 2019, A RE-EXCISION SURGERY WAS NEEDED AND THE BIOZORB WAS REPOSITIONED DURING THIS PROCEDURE, THERE WERE NO COMPLICATIONS REPORTED. ON (B)(6) 2019, THE PATIENT WAS SEEN IN OFFICE AND HAD A HEMATOMA ASPIRATED BY THE PHYSICIAN, BUT ON (B)(6) 2019, PIECES OF BIOZORB WERE OBSERVED THROUGH THE SKIN, THE BIOZORB WAS REMOVED ON (B)(6) 2019. THE PHYSICIAN REPORTED THAT THE PATIENT WAS TREATED WITH AUGMENTIN AFTER HAVING THE HEMATOMA ASPIRATED BUT PRIOR TO BIOZORB REMOVAL. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Hematoma

  MAUDE report 21675762 ↗
• InjuryMar 24, 2025Break; Fracture; Migration or Expulsion of Device; Break; Fracture; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT HAD A LUMPECTOMY AND BIOZORB PLACEMENT ON (B)(6) 2017. THE PATIENT PRESENTED ON AN UNKNOWN DATE WITH SEVERAL PIECES OF THE DEVICE EXTRUDING THROUGH THE WOUND AND A REVISION AND REMOVAL OF REMAINING BIOZORB WAS COMPLETED ON (B)(6) 2019. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21675745 ↗
• InjuryMar 24, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A PATIENT RECEIVED A BIOZORB DEVICE ON (B)(6) 2018, AND PRESENTED WITH REDNESS/CELLULITIS ON RIGHT BREAST SOON AFTER A RE-EXCISION SURGERY IN (B)(6) 2018. THE PATIENT WAS PLACED ON ANTIBIOTICS (CLINDAMYCIN, THEN BACTRIM, THEN VANCOMYCIN IV); ADMITTED TO THE HOSPITAL AND SENT HOME ON ORAL BACTRIM. CULTURE TAKEN DURING HOSPITAL ADMISSION REVEALED STAPH AUREUS GROWTH. PATIENT RECEIVED PARTIAL XRT IN (B)(6) 2018. IN (B)(6) 2018, THE PATIENT PRESENTED WITH CELLULITIS OF THE SAME BREAST WHICH WAS TREATED UNSUCCESSFULLY WITH BACTRIM UP UNTIL (B)(6)2018, IN WHICH WAS EVALUATED, AND IT WAS DECIDED TO REMOVE THE BIOZORB AS IT COULD BE OBSERVED PROTRUDING THROUGH THE SKIN. ON (B)(6) 2018, THE BIOZORB WAS REMOVED AND THE WOUND HEALED CORRECTLY. PATIENT WAS DOING FINE ON (B)(6)2019. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Bacterial Infection; Erythema

  MAUDE report 21675102 ↗
• InjuryMar 24, 2025Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT RECEIVED A BIOZORB MARKER ON (B)(6) 2017, DURING A LUMPECTOMY. PATIENT PRESENTED ON (B)(6) 2018, WITH CELLULITIS OF THE RIGHT BREAST. THE PATIENT WAS STARTED ON ANTIBIOTICS, AND IT WORSENED WITH SUBSEQUENT SKIN BREAKDOWN AND WOUND DEHISCENCE. SWITCHED TO DIFFERENT ANTIBIOTIC, NO CULTURE OF THE EXUDATE TAKEN. PIECES OF BIOZORB WERE EXPELLED FROM WOUND AND REMOVED IN THE OFFICE SETTING. ON (B)(6) 2019, THE DEVICE WAS COMPLETELY REMOVED IN THE OPERATING ROOM. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Bacterial Infection; Wound Dehiscence

  MAUDE report 21675094 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A BIOZORB PLACEMENT ON (B)(6) 2018, AND EXPERIENCED PAIN FROM THE ORIGINAL PLACEMENT THAT INCREASED AFTER A RE-EXCISION SURGERY (2 WEEKS AFTER DUE TO POSITIVE MARGINS). THE PATIENT RECEIVED RADIATION IN (B)(6) 2018 AND THE BIOZORB WAS REMOVED ON (B)(6) 2018, DUE TO PATIENT´S INTOLERABLE PAIN. PATIENT WAS REPORTED DOING BETTER POST-SURGERY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 21675092 ↗
• InjuryMar 24, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2018, A PATIENT RECEIVED A BIOZORB DEVICE AFTER LUMPECTOMY. ON (B)(6) 2018, THE BIOZORB WAS REMOVED DUE TO A MASTECTOMY DUE TO POSITIVE MARGINS AND THE DEVICE WAS FOUND TO BE IN 2 PIECES. THE PRODUCT WAS RETURNED FOR INVESTIGATION. THE PATIENT WAS REPORTED TO HAVE CHEMOTHERAPY ON UNKNOWN DATES AND ADDITIONALLY AN INFECTION POSITIVE FOR STAPH AUREUS ON AN UNKNOWN DATE. NO OTHER INFORMATION COULD BE OBTAINED.

  Patient problems: Bacterial Infection

  MAUDE report 21674917 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A BIOZORB MARKER ON (B)(6) 2018, DURING A LUMPECTOMY. AFTER THE PROCEDURE THE PATIENT WAS REPORTED TO HAVE A HEMATOMA DRAINED ON (B)(6) 2018, PATIENT WAS REPORTED TO BE ON BLOOD THINNERS, ANTIBIOTICS WERE STARTED ON (B)(6) 2018. PATIENT WAS SCHEDULED FOR PERIODICAL CONTROLS FROM MARCH 5TH UP UNTIL 13TH IN WHICH ASPIRATIONS AND WOUND CARE WAS PERFORMED. ON (B)(6) 2018, DUE TO THE WOUND NOT HEALING IT WAS DECIDED TO REMOVE THE BIOZORB MARKER WHICH WAS REMOVED ON (B)(6) 2018. NO CULTURES DONE OF ANY FLUID AT ANY POINT. PATIENT WAS REPORTED TO RECEIVE RADIOTHERAPY FROM (B)(6) 2018.

  Patient problems: Hematoma; Impaired Healing; Post Operative Wound Infection

  MAUDE report 21674915 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6)2017, A PATIENT RECEIVED A BIOZORB MARKER DURING A LUMPECTOMY. THE PATIENT HAD TO HAVE A RE-EXCISIONS SURGERY DUE TO POSITIVE MARGINS AND PORT PLACEMENT ON (B)(6)2017. ON (B)(6) THE PATIENT PRESENTED WITH SWELLING IN HER BREAST AND FROM (B)(6)UP UNTIL (B)(6)2017, THE PATIENT HAD SEROMA REMOVED AND ASPIRATED, INFECTIONS SIGNS TREATED WITH ANTIBIOTICS AND THE WOUND BECAME LARGER AND OPENED AND THE PHYSICIAN DECIDED TO REMOVE THE MARKER ON (B)(6)2017. IN (B)(6)2017 THE PATIENT CAME BACK TO THE OFFICE AND THE WOUND HAD CLOSED AND WAS HEALING. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Bacterial Infection; Seroma; Swelling/ Edema; Wound Dehiscence

  MAUDE report 21674837 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT A PATIENT RECEIVED A BIOZORB DEVICE ON (B)(6) 2018. THE PATIENT WAS REPORTED AS EXPERIENCING RECURRENT SEROMA FOR WHICH SHE RECEIVED FIVE ASPIRATIONS AND SIGNIFICANT TISSUE MOBILIZATION. THE SURGEON FROM HER CASE REPORTED THAT HER PATIENT´S SEROMA WAS A RESULT OF COMBINATION OF FACTORS (EXTENSIVE TISSUE MOBILIZATION, PROXIMITY TO AXILLA, SENTINEL NODE BIOPSY THROUGH THE SAME INCISION AND PATIENT FACTORS). THE PHYSICIAN REPORTED THAT ASPIRATION AND COMPRESSION DRESSINGS WERE THE TREATMENT FOR THESE EVENTS. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Seroma

  MAUDE report 21674815 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A BIOZORB ON (B)(6) 2018, PHYSICIAN REPORTED THAT THE INFECTION WAS NOT CAUSED BY THE BIOZORB MARKER, THE PHYSICIAN REPORTED THAT THE PATIENT DEVELOPED AN INFECTION FROM AN AXILLARY SEROMA THAT WAS DRAINED ON (B)(6) 2018. THE PHYSICIAN LATER REPORTED THAT HE DECIDED TO REMOVE THE BIOZORB DUE TO THE PATIENT BEING EXPOSED TO RADIATION LATER. THE PATIENT WAS REPORTED TO BE DOING FINE.

  Patient problems: Bacterial Infection; Seroma

  MAUDE report 21674814 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A BIOZORB DEVICE IMPLANTATION ON (B)(6) 2018, EARLY (B)(6) THE PATIENT PRESENTED TO THE PHYSICIAN WITH SWELLING AND ECCHYMOSIS IN THE LUMPECTOMY AREA, TREATED WITH SURVEILLANCE AND COMPRESSES. ON (B)(6) 2018, THE PATIENT RETURNED TO THE SURGEON WITH A LOCALIZED ABSCESS, THE FLUID WAS ASPIRATED WHICH RETURNED POSITIVE FOR ACTINOMYCES AND TREATED WITH ANTIBIOTICS. ON (B)(6), THE PATIENT RETURNED WITH OPEN WOUND AND DRAINING FLUID. AFTER MULTIPLE TREATMENTS AND WOUND OPENING THE PHYSICIAN REMOVED THE DEVICE ON (B)(6) 2018, AND WAS REFERRED FOR INFECTIOUS DISEASES. THE PATIENT WAS REPORTED DOING WELL.

  Patient problems: Abscess; Ecchymosis; Seroma; Swelling/ Edema

  MAUDE report 21674812 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A LUMPECTOMY AND BIOZORB PLACEMENT ON (B)(6) 2017. ON (B)(6) 2017, THE PATIENT WAS ON BACTRIM, THEN THE WOUND BEGAN DRAINING, NO CULTURE WAS PERFORMED. ON (B)(6) 2017, THE PATIENT BEGAN RADIATION THERAPY. A MAMMOGRAM AND ULTRASOUND WERE DONE ON (B)(6) 2017 - BIRADS 2, WITH NO MENTION OF BIOZORB IN THE REPORT. THE SURGEON REPORTED THAT AT 6 MONTHS FOLLOW UP, AFTER RADIATION TREATMENT, THE PATIENT PRESENTED WITH WOUND BREAKDOWN AND THE DEVICE WAS VISIBLE WITHIN THE WOUND. THE SURGEON REPORTED THAT THE DEVICE WAS REMOVED ON (B)(6) 2018. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Bacterial Infection; Post Operative Wound Infection; Wound Dehiscence

  MAUDE report 21674759 ↗