ROHO QUADTRO SELECT HIGH PROFILE Cushion QS910CRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613732054229), received between Sep 11, 2023 and Aug 28, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Product Quality Problem” (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 18, 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.

• InjuryAug 28, 2026Product Quality Problem

  Distributor reported that their end user reported that she had fallen out of her chair and broke a hip. The user asserted that her ROHO cushion had gone flat, causing her to lose her balance and fall from the chair. The user had reported difficulty with keeping the cushion inflated requiring daily inflation.

  Patient problems: Bone Fracture(s); Fall; Hip Fracture

  MAUDE report 50498119 ↗
• InjurySep 11, 2023Use of Device Problem; Use of Device Problem

  CUSTOMER CLAIMS THAT HE DEVELOPED A INJURY DUE TO UTILIZING CUSHION IN OVERINFLATED STATE.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 17720290 ↗