MODULINE 83931814Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04055207062098), received between Feb 20, 2019 and Feb 20, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Integrity 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionFeb 20, 2019Material Integrity Problem; Material Integrity Problem

  THE USER FACILITY RETURNED THE DEVICE TO RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) ON JUNE 26, 2019 AND THE DEVICE EVALUATION WAS COMPLETED ON JULY 17, 2019. THE DEVICE WAS VISUALLY AND FUNCTIONALLY EVALUATED USING A MAGNIFIER. THE INSTRUMENT WAS FOUND TO HAVE BEEN REPAIRED BY A THIRD PARTY; AS A RESULT, THE REPORTED CONDITION COULD NOT BE VERIFIED. A PROBABLE ROOT CAUSE COULD NOT BE DETERMINED AS THE INSTRUMENT WAS REPAIRED BY A THIRD PARTY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8353592 ↗