ook cocoon FL36 ook cocoonRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00670482000111), received between Mar 29, 2018 and Jul 30, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Misassembled During Manufacturing /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. 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.

• MalfunctionJul 30, 2021Mechanical Problem; Mechanical Problem

  TECHNICAL SUPPORT OF MANUFACTURE WAS INFORM THAT HEAD SIDERAIL SPRING WAS MISSING AND IT WAS ADDITIONALLY MENTION THAT A NUT OF TRANSFERT PLATE WAS ALSO MISSING. THERE WAS NO FURTHER CONSEQUENCE THAT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12252524 ↗
• MalfunctionMar 29, 2018Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT A FASTENER FELT OFF FROM A SIDERAIL TRANSFER PLATE WHILE THE DEVICE, A OOK-COCOON MEDICAL BED, WAS BEING INSPECTED PRIOR TO INITIAL INSERVICING. THIS WAS A OUT OF THE BOX ISSUE, THE DEVICE HAD NOT BEEN PUT IN SERVICE.

  Patient problems: No Patient Involvement

  MAUDE report 7381226 ↗