POSEY 8021Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10190676000552), received between Mar 6, 2024 and Mar 6, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Positioning Failure” (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

Recent adverse event reports

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

• MalfunctionMar 6, 2024Positioning Failure; Positioning Failure

  CUSTOMER REPORTING A COMPLAINT ON PRODUCT 8021 FILLER CUSHIONS. CUSTOMER STATES THAT THE IFU RECOMMENDS USING 8021 WHEN A PATIENT REQUIRES TUBE FEEDING TO RAISE THE HEAD OF THE BED. WHILE USING THE PRODUCT FOR THIS PURPOSE THE CUSHION DOESN'T WORK AND ENDS UP FALLING ON THE CUSTOMER'S HEAD OVER TIME. THERE HAS BEEN DISTRIBUTOR FEEDBACK THAT CONFIRMS THE FILLER CUSHION WILL NOT STAY IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18852047 ↗