Ear and Ulcer Syringe 0035820Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741049279), received between May 2, 2018 and Oct 21, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATERIAL WAS FOUND IN DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 10712537 ↗
• MalfunctionMay 3, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE USER FOUND FOREIGN MATERIAL ATTACHED ON OR IN THE SYRINGE. THIS EVENT OCCURRED WHEN OPENING THE PACKAGE, SO THE SYRINGE WAS REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7482688 ↗
• MalfunctionMay 2, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE USER FOUND THAT A FOREIGN MATERIAL WAS ATTACHED ON OR IN THE DEVICE PRIOR TO OPENING THE PACKAGE. ANOTHER DEVICE WAS USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7481054 ↗