HydroMark CA000413001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841911100133), received between May 27, 2022 and May 27, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Use of Device Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT DR. (B)(6) SHEARED MARKER OFF INTO BREAST OF PATIENT. HE USED THIS MARKER DOWN BACK OF REVOLVE 10G NEEDLE. THE CLINIC AND DOCTOR WERE MADE AWARE THAT IT WOULD NEED TO BE REMOVED FROM PATIENT IMMEDIATELY. PATIENT WAS UNAWARE OF WHAT HAPPENED. DR. (B)(6) HAS BEEN ADVISED TO LET THE PATIENT KNOW THAT THE SPRING WOULD NEED TO BE SURGICALLY REMOVED. I HAVE LET THE FACILITY KNOW THAT THE SHEARED OFF SPRING NEEDS TO BE SURGICALLY REMOVED FROM THE PATIENT. AT THE TIME I WAS MADE AWARE OF THE EVENT, THE PATIENT WAS STILL UNAWARE OF WHAT HAD ACTUALLY HAPPENED. SHE WAS NOT HARMED DURING THE ACTUAL BIOPSY PROCEDURE. THEY WERE GOING TO INFORM HER WHAT HAD HAPPENED AND THAT A SURGERY WOULD NEED TO OCCUR TO REMOVE THE SHEARED OFF TIP.

  Patient problems: Foreign Body In Patient

  MAUDE report 14525100 ↗