ROHO QUADTRO SELECT HIGH PROFILE Cushion QS1111CRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613732054366), received between May 28, 2026 and May 28, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Use of Device 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2026Use of Device Problem

  END USER RECEIVED TREATMENT FOR A STAGE 3 PRESSURE ULCER AT THE WOUND CARE CLINIC. STAFF AT THE CLINIC DETERMINED THE USER NEEDED A NEW ROHO CUSHION SINCE THE USERS CURRENT ROHO CUSHION WAS NOT HOLDING AIR. THE PRESCRIPTION FOR THE REPLACEMENT CUSHION WAS SUBMITTED TO NATIONAL SEATING AND MOBILITY ON (B)(6) 2026, WHO THEN REPORTED THIS TO ROHO, INC. THE USER WAS UNABLE TO SPECIFY HOW LONG SINCE HER PRESSURE ULCER HAD DEVELOPED, ONCE SHE DISCOVERED DRAINAGE SHE WENT TO THE WOULD CARE CLINIC FOR TREATMENT.

  Patient problems: Pressure Sore/Ulcer; Tissue Breakdown

  MAUDE report 25323703 ↗