Tumark® Professional Q for Brevera® Petite Tumark-BREV-P-QRecalls & reported problems
SOMATEX Medical Technologies GmbH · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04250195611338), received between Dec 11, 2024 and Dec 11, 2024 — classified as 3 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- Inflammation2
- Foreign Body Reaction1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HOLOGIC RECEIVED INFORMATION THROUGH A RETROSPECTIVE SURVEY RELATED TO PATIENT RECORDS. IT WAS DOCUMENTED THAT ON AN UNKNOWN DATE IN (B)(6) 2024 A PATIENT EXPERIENCED INFLAMMATION THAT RESOLVED WITHOUT MEDICAL INTERVENTION. THE ISSUE WAS REPORTED AS HAPPENED 1 MONTH AFTER IMPLANTATION. NO OTHER INFORMATION WAS AVAILABLE.
Patient problems: Inflammation
MAUDE report 20906894 ↗InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HOLOGIC RECEIVED INFORMATION THROUGH A RETROSPECTIVE SURVEY RELATED TO PATIENT RECORDS. IT WAS DOCUMENTED THAT ON AN UNKNOWN DATE ON (B)(6) 2021 A PATIENT EXPERIENCED AN INFLAMMATION THAT REQUIRED MEDICAL INTERVENTION WITHIN THE FIRST WEEK OF IMPLANTATION. NO OTHER INFORMATION WAS AVAILABLE.
Patient problems: Inflammation
MAUDE report 20906883 ↗InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HOLOGIC RECEIVED INFORMATION THROUGH A RETROSPECTIVE SURVEY RELATED TO PATIENT RECORDS. IT WAS DOCUMENTED THAT ON AN UNKNOWN DATE IN (B)(6) 2024 A PATIENT EXPERIENCED A FOREIGN BODY REACTION THAT RESOLVED WITHOUT MEDICAL INTERVENTION. THE ISSUE WAS REPORTED AS HAPPENED 1 MONTH AFTER IMPLANTATION. NO OTHER INFORMATION WAS AVAILABLE.
Patient problems: Foreign Body Reaction
MAUDE report 20906454 ↗
Other Marker, Radiographic, Implantable devices
- BioZorb F0202Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls192 reports
- BioZorb F0221Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE3 recalls15 reports
- BioZorb F0203Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls51 reports
- BioZorb F0231Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls19 reports
- BioZorb F0303Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls19 reports
- BioZorb F0304Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls19 reports
- BioZorb F0404Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls6 reports
- BioZorb F0331Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls4 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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