Generic Turning MattressRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00845699005802), received between Oct 16, 2025 and Oct 16, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryOct 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON 18-SEPT-2025 AGILITI BECAME AWARE OF AN INCIDENT THAT WAS REPORTED TO HAVE TAKEN PLACE ON (B)(6) 2024 AT THE (B)(6) HOSPITAL'S (B)(6) IN THE UK. ON (B)(6) 2024 REPORT WAS SUBMITTED BY CUSTOMER TO GOV.UK/MHRA (UK MEDICINES & HEALTHCARE PRODUCTS REGULATORY AGENCY) STATING THE FOLLOWING: "PARAPLEGIC PATIENT RIGHT LEG HAS BECOME TRAPPED BETWEEN THE EDGE OF THE MATTRESS AND THE SIDES OF THE BED, ON TURN SCHEDULE EVERY 90 MINS. BED TURNING TO THE LEFT THE PATIENT HEARD A CRACK AND WAS CONCERNED HE HAD BROKEN SOMETHING SO ALERTED STAFF. X RAY HAS CONFIRMED FRACTURE RIGHT NECK OF FEMUR" ON (B)(6) 2025 AGILITI RECEIVED ADDITIONAL INFORMATION STATING THAT THE REPORTER OF THE INCIDENT ADVISED THAT THE BED FRAME WAS A PLUG IN BED THAT RAISES AND LOWERS WITH SPLIT SIDE RAILS, AND NEITHER THE MANUFACTURER'S NAME NOR MODEL WERE CONFIRMED. THE BED WAS MOVED TO ANOTHER LOCATION, WAS NOT ISOLATED, AND CAN NO LONGER BE LOCATED.

  Patient problems: Limb Fracture

  MAUDE report 23319130 ↗