Ear and Ulcer Syringe 0035830Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741049286), received between Jan 31, 2018 and Jul 5, 2018 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 5, 2018Contamination

  IT WAS REPORTED THAT THE FOREIGN MATERIAL LIKE OIL, WAS ATTACHED TO THE DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7664275 ↗
• MalfunctionMay 15, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE USER FOUND THAT THERE WAS FOREIGN MATERIAL IN THE SYRINGE. WHEN IT WAS USED FOR THE PATIENT, THE FOREIGN MATERIAL CAME OUT FROM THE SYRINGE. NO PATIENT INJURY REPORTED.

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

  MAUDE report 7516434 ↗
• MalfunctionApr 27, 2018Break; Break; Material Fragmentation

  IT WAS REPORTED THE PATIENT WAS UNDERGOING A LUMPECTOMY. THE BULB SYRINGE WAS OPENED DURING THE CASE AND A SMALL PIECE OF GREEN PLASTIC MATCHING THE GREEN PLASTIC OF THE BULB CAME OUT OF THE BULB WHEN IT WAS BEING USED TO IRRIGATE. THE PIECE WAS REMOVED FROM THE SURGICAL FIELD.

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

  MAUDE report 7468870 ↗
• MalfunctionApr 23, 2018Break; Detachment Of Device Component

  IT WAS REPORTED THAT THE EAR AND ULCER SYRINGE HAD A PIECE COME OFF DURING SURGERY WHILE IRRIGATING THE SURGICAL WOUND. THE COMPLAINANT REPORTED THAT THE BROKEN PIECE WAS RETRIEVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7453046 ↗
• MalfunctionApr 23, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE USER FOUND THAT THERE WAS FOREIGN MATERIAL IN THE SYRINGE. DURING USE ON THE PATIENT, THE FOREIGN MATERIAL CAME OUT FROM THE SYRINGE. NO PATIENT INJURY WAS REPORTED.

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

  MAUDE report 7453022 ↗
• MalfunctionJan 31, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A GREEN COLORED FOREIGN MATERIAL CAME OUT OF THE SYRINGE. TWO SYRINGES WERE USED, BUT THE USER WAS UNABLE TO IDENTIFY WHICH SYRINGE THE MATERIAL CAME FROM. THE SYRINGES WERE NOT USED ON THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 7231787 ↗
• MalfunctionJan 31, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A GREEN COLORED FOREIGN MATERIAL CAME OUT OF THE SYRINGE. TWO SYRINGES WERE USED, BUT THE USER WAS UNABLE TO IDENTIFY WHICH SYRINGE THE MATERIAL CAME FROM. THE SYRINGES WERE NOT USED ON THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 7231278 ↗