TUMARK Q 271500Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04250195603081), received between May 24, 2017 and Jun 5, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Contamination” (1 report).

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.

• InjuryJun 5, 2020Degraded; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION HAS BEEN SENT BY (B)(6) TO SOMATEX MEDICAL TECHNOLOGIES (B)(4): PATIENT (FEMALE, (B)(6)) CAME (B)(6) 2020 TO THE CLINIC FOR TUMORS ( ZAGREB) BECAUSE OF INFLAMMATION ON THE BREAST. AFTER EXAMINATION WITH ULTRASOUND AND MAMMOGRAPHY, PATIENT WAS RECOMMENDED BIOPSY. DURING BIOPSY, MARKATION WAS LEFT IN THE BREAST WITHOUT PATIENT KNOWLEDGE USING TUMARK Q. PATIENT WAS NOT ASKED IF SHE HAD ANY ALLERGIES TO NI (NITIOL). TUMARK Q, LENGTH 12 CM, DIAMETER 18G, REF 271500, LOT 18132 WAS USED ON THE PATIENT. (B)(6) 2020 PATIENT REPORTS TO THE SAME CLINIC TO PICK UP TEST RESULTS AND COMPLAINED TO THE DOCTOR ABOUT ITCHING AND STINGING FEELING IN THE BREAST. DOCTOR ASSURES HER THAT IT IS A NORMAL FEELING BECAUSE OF CARCINOM. AFTER SENDING HOME, PATIENT DOES NOT FEEL WELL AND TAKES ANALGETICS AND THAT AFTERNOON DUE TO UNBEARABLE PAIN AND STINGING REPORTS TO THE EMERGENCY UNIT IN CLINIC FOR TUMORS (ZAGREB) WHERE SHE WAS SENT AWAY. IN EMERGENCY UNIT IN ANOTHER HOSPITAL SHE IS TREATED WITH ANTIBIOTICS AND AGAIN SENT HOME. ON (B)(6) 2020 PATIENT IS EXAMINED WITH ULTRASOUND AND COLOR DOPPLER IN PRIVATE CLINIC. MARKATION AND Q TIP ARE DISPLACED AND DISINTEGRATED AND ON THE BREAS

  Patient problems: Burning Sensation; Itching Sensation; Pain

  MAUDE report 10122071 ↗
• MalfunctionMay 24, 2017Detachment Of Device Component; Contamination; Nonstandard Device; Material Puncture/Hole

  STERILE PACKAGE WAS PUNCTURED. THE CANNULA SYSTEMS OF THIS PRODUCT CODE ARE PACKAGED IN SOFT BLISTERS. THERE IS A PROTECTIVE TUBE OVER THE CANNULA TO PREVENT THE RISK OF PUNCTURE OF THE PACKAGING MATERIAL. ONE PROTECTIVE TUBE DETACHED FROM THE CANNULA AND THE CANNULA PUNCTURED THE PACKAGE. THE PACKAGING OF THE PRODUCT WAS PUNCTURED, WHICH RESULTED IN THE PRODUCT BEING NON-STERILE. THE COMPLAINED PRODUCT HAS NOT BEEN USED.

  Patient problems: No Patient Involvement

  MAUDE report 6587291 ↗