ROHO LOW PROFILE Single Compartment Cushion 1R109LPCRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613732005535), received between Nov 26, 2025 and Nov 26, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Gas/Air Leak” (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.

• InjuryNov 26, 2025Gas/Air Leak; Material Integrity Problem; Naturally Worn; Gas/Air Leak; Material Integrity Problem; Naturally Worn

  USER CALLED TO REPORT HE HAD JUST RETURNED FROM VACATION AND HIS CUSHION DEVELOPED A LEAK WHILE ON VACATION. HE HAS PATCHED THE CUSHION SEVERAL TIMES BUT WAS UNABLE TO GET THE PATCH TO STOP THE LEAK. HE STATED THAT HE HAS DEVELOPED A PRESSURE SORE ON HIS BUTTOCKS DUE TO THE DEFLATED CUSHION. THE CUSHION WAS RETURNED TO ROHO FOR EVALUATION ON 11/6/2025. EVALUATION OF THE CUSHION SHOWED ONE OF THE PATCHES WAS LEAKING AIR. THE CELL WITH THE LEAKING PATCH WAS DISSECTED AND IT WAS DETERMINED THERE WAS A TEAR UNDER THE PATCH WHICH WAS LIKELY TOO LARGE FOR THE PATCH TO STOP THE LEAK. THERE WAS ANOTHER PATCH ON THE SAME CELL WHICH ALSO HAD A TEAR UNDERNEATH IT BUT THIS PATCH WAS PROPERLY SEALED. THE INSIDE OF THE LEAKING CELL SHOWED SIGNS OF FATIGUE INCLUDING A CREASE. A REPLACEMENT CUSHION WAS PROVIDED TO THE USER.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 23657766 ↗