Ear and Ulcer Syringe 0935830Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10801741075992), received between Aug 9, 2017 and Aug 15, 2019 — classified as 3 malfunctions.

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

• MalfunctionAug 15, 2019Material Deformation

  IT WAS REPORTED THAT THE BULB SYRINGE SEEMED DEFORMED.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 8898779 ↗
• MalfunctionJun 6, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL INSIDE OF THE SYRINGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7575663 ↗
• MalfunctionAug 9, 2017Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A BUG CAME OUT OF THE SYRINGE ONCE IT WAS FILLED WITH SALINE. IT WAS LATER REPORTED THAT THE EAR SYRINGE WAS FILLED WITH SALINE AND WHEN USED TO FLUSH OUT THE SURGICAL INCISION, A BUG CAME OUT OF EAR SYRINGE. THE STAFF STATED THAT THERE WAS NO BUG IN THE SALINE IN THE BOWL PRIOR TO FILLING THE SYRINGE.

  Patient problems: No Information

  MAUDE report 6780035 ↗