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Grass F-E2-48Recalls & reported problems

Natus Manufacturing Limited · Genuine GRASS Platinum Subdermal Needle Electrodes-Reusable · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00382830017268), received between Dec 16, 2019 and Dec 16, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1
  • Defective Component1
  • Material Separation1

Patient problems

  • No Information1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 16, 2019Break; Material Separation; Defective Component; Break; Material Separation; Defective Component

    F-E2-48 SUBDERMAL NEEDLE SEPARATED FROM HUB IN THE PATIENT DURING PROCEDURE, NEEDLE WAS LEFT IN PATIENT IN THE ANTERIOR TIBIALIS LOCATION AS THAT WAS THE HOSPITALS PROTOCOL IN THIS SITUATION.

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

    MAUDE report 9473199 ↗

Other Electrode, Cutaneous devices

All Electrode, Cutaneous devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.