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Wayne G07910Recalls & reported problems

Cook Incorporated · Wayne Pneumothorax Set · 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 00827002079106), received between Dec 16, 2022 and Dec 16, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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

  • Device Contaminated During Manufacture or Shipping1
  • Manufacturing, Packaging or Shipping Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionDec 16, 2022Device Contaminated During Manufacture or Shipping; Manufacturing, Packaging or Shipping Problem; Device Contaminated During Manufacture or Shipping; Manufacturing, Packaging or Shipping Problem

    IT WAS REPORTED THAT DURING DEVICE STOCKING, A NURSE FOUND A HAIR-LIKE SUBSTANCE IN THE SEALED PACKAGE OF A WAYNE PNEUMOTHORAX SET. NO PATIENT CONTACT WAS MADE. NO ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15999393 ↗

Other CATHETER AND TIP, SUCTION devices

All CATHETER AND TIP, SUCTION devices →

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