SR PIP 17-1327Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00886385019864), received between Sep 4, 2019 and Sep 4, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (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 16, 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.

• MalfunctionSep 4, 2019Naturally Worn

  UPON INCOMING INSPECTION, ITEMS WERE VISIBLY WORN. NO ASSOCIATED PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8962915 ↗
• MalfunctionSep 4, 2019Naturally Worn

  UPON INCOMING INSPECTION, ITEMS WERE VISIBLY WORN. NO ASSOCIATED PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8962913 ↗