ROHO CONTOUR SELECT Cushion CS1211CRecalls & reported problems
Roho, Inc. · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613732077303), received between Feb 2, 2026 and Feb 2, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Integrity 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.
Reports received per month
Most reported problems
Device problems
- Material Integrity Problem1
- Material Split, Cut or Torn1
Patient problems
- Tissue Breakdown1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 2, 2026Material Integrity Problem; Material Split, Cut or Torn
THE DEALER REPORTED THEIR USER HAS A CONTOUR SELECT CUSHION WHICH THE USER HAS COMPLAINED CONTINUES TO DEFLATE. THE DEALER HAS VISITED THE USER SEVERAL TIMES AND THE CUSHION APPEARED TO INFLATE PROPERLY AT EACH VISIT. AFTER THEIR VISIT THE RIGHT FRONT QUADRANT OF THE CUSHION DEFLATES. THE DEALER HAS BEEN UNABLE TO IDENTIFY A LEAK BUT THE USE HAS DEVELOPED A PRESSURE WOUND ON HIS BUTTOX WHICH HAS REQUIRED DAILY VISITS BY WOUND CARE FOR HEALING.
Patient problems: Tissue Breakdown
MAUDE report 24230087 ↗
Other Cushion, Flotation devices
- MEDLINE MSCBUB1818Medline Industries, Inc. · CUSHION, FLOTATION10 reports
- MEDLINE MSCBUB1818VLMedline Industries, Inc. · CUSHION, FLOTATION4 reports
- ROHO QUADTRO SELECT HIGH PROFILE Cushion QS1011CRoho, Inc. · Cushion, Flotation3 reports
- Medline MSCBUB2822VLMedline Industries, Inc. · CUSHION, FLOTATION3 reports
- ROHO QUADTRO SELECT HIGH PROFILE Cushion QS1010CRoho, Inc. · Cushion, Flotation3 reports
- ROHO QUADTRO SELECT HIGH PROFILE Cushion QS910CRoho, Inc. · Cushion, Flotation2 reports
- ROHO QUADTRO SELECT HIGH PROFILE Cushion QS89CRoho, Inc. · Cushion, Flotation2 reports
- MEDLINE MSCBUB2822Medline Industries, Inc. · CUSHION, FLOTATION2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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