Trigen E0016884-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556777640), received between Aug 11, 2020 and Nov 6, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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.

• InjuryNov 6, 2020Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE DEVICE WAS BROKE INSIDE THE PATIENT. THE PROCEDURE HAD A DELAY BETWEEN 0-30 MIN. IT IS UNKNOWN HOW WAS THE PROCEDURE FINISHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10805125 ↗
• InjuryAug 11, 2020Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE DEVICE WAS BROKE INSIDE THE PATIENT. THE PROCEDURE HAD A DELAY BETWEEN 0-30 MIN. IT IS UNKNOWN WHEN THE EVENT OCCURRED AND HOW WAS THE PROCEDURE FINISHED. ANY OTHER ISSUE THAT COULD AFFECT THE PATIENT'S CONDITION WAS NOT REPORTED BY THIS EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10394004 ↗