Ear and Ulcer Syringe 9035820Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10801741075985), received between Nov 13, 2019 and Dec 17, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Decrease in Suction” (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 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.

• MalfunctionDec 17, 2019Device Damaged Prior to Use; Device Damaged Prior to Use; Structural Problem; Suction Failure

  IT WAS REPORTED THAT THE BULB SYRINGE IN THE VAGINAL DELIVERY KITS WERE FLAT. THEY TRIED TO SUCTION A BABY AT DELIVERY AND THE BULB SYRINGE WOULD NOT FUNCTION.

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

  MAUDE report 9484032 ↗
• MalfunctionNov 13, 2019Suction Problem; Decrease in Suction; Suction Problem

  IT WAS REPORTED THAT THE BULB SYRINGE IN THE VAGINAL DELIVERY KITS WERE FLAT. THE HEALTH PROFESSIONAL STATED, WHILE TRYING TO SUCTION A BABY AT DELIVERY, THE BULB SYRINGE WOULD NOT FUNCTION. NO MEDICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 9315390 ↗