PRO-DENSE 87SRIN04Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00840420140791), received between Oct 3, 2022 and Oct 3, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 3, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN THE INNER PACKAGE WAS OPENED, THERE WAS SOME LIQUID ON THE BOTTLE, AND THE LABEL WAS WET. THIS EVENT CAUSED THE SURGERY TO BE DELAYED BY TWO HOURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15533019 ↗
• MalfunctionOct 3, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN THE INNER PACKAGE WAS OPENED, THERE WAS SOME LIQUID ON THE BOTTLE, AND THE LABEL WAS WET. THIS EVENT CAUSED THE SURGERY TO BE DELAYED BY TWO HOURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15532009 ↗
• MalfunctionOct 3, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN THE INNER PACKAGE WAS OPENED, THERE WAS SOME LIQUID ON THE BOTTLE, AND THE LABEL WAS WET. THIS EVENT CAUSED THE SURGERY TO BE DELAYED BY TWO HOURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15531665 ↗
• MalfunctionOct 3, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN THE INNER PACKAGE WAS OPENED, THERE WAS SOME LIQUID ON THE BOTTLE, AND THE LABEL WAS WET. THIS EVENT CAUSED THE SURGERY TO BE DELAYED BY TWO HOURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15530974 ↗