HydroMark 4010-01-11-T3Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841911101437), received between Sep 4, 2019 and Sep 4, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 reports).

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 4, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  DEVICOR MEDICAL PRODUCTS, INC. RECEIVED A REPORT FROM THE DISTRIBUTOR STATING, "MARKER CLIP WAS INSERTED IN (B)(6) 2018. PATIENT FOLLOW UP IN (B)(6) 2019 SHOWED A NEW NODULE AROUND THE CLIP. SUSPECTED TO BE A REACTION TO THE GEL MARKER CLIP. MARKER IS STILL IN PATIENT'S BREAST AND NOT REMOVED". THIS HAD BEEN DOCUMENTED IN OUR SYSTEM AS REPORT # (B)(4).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8959919 ↗
• InjurySep 4, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  DEVICOR MEDICAL PRODUCTS, INC. RECEIVED A REPORT FROM THE DISTRIBUTOR STATING, "MARKER CLIP WAS INSERTED IN (B)(6) 2018. PATIENT FOLLOW UP IN (B)(6) 2019 SHOWED A NEW NODULE AROUND THE CLIP. SURGICAL EXCISION OF THE NODULE SHOWS THIS IS A FOREIGN BODY GRANULOMA, SUSPECTED TO BE A REACTION TO THE GEL MARKER CLIP". THIS HAS BEEN DOCUMENTED IN OUR SYSTEM AS RECORD # (B)(4).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8959868 ↗