ROHO QUADTRO SELECT HIGH PROFILE Cushion QS1011CRecalls & reported problems
Roho, Inc. · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613732054328), received between May 2, 2023 and Aug 15, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 Split, Cut or Torn1
- Mechanical Problem1
- Use of Device Problem1
Patient problems
- Pressure Sore/Ulcer2
- Skin Erosion1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 15, 2025Mechanical Problem; Mechanical Problem
DISTRIBUTOR (B)(4) DELIVERED A ROHO CUSHION QS1011C ON JUNE 15,2025. AFTER DELIVERY, THE END USER NOTICED THE CUSHION WAS FLAT BY THE END OF THE DAY. A TECHNICIAN FROM THE DISTRIBUTOR INSPECTED THE CUSHION AND DETERMINED THE ISOFLO VALVE WAS LEAKING. A NEW CUSHION WAS ISSUED UNDER WARRANTY. AFTER THE INITIAL WARRANTY CLAIM WAS RECEIVED, THE END USER CONTACTED THE DISTRIBUTOR IN ORDER TO REPORT THAT A PRE-EXISTING PRESSURE SORE INJURY HAD REOPENED DUE TO THE CUSHION GOING FLAT. THE END USER CLAIMED THE PRESSURE SORE IS NOW A STAGE 10 WOUND.
Patient problems: Skin Erosion
MAUDE report 22819785 ↗InjuryOct 2, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
CUSTOMER CLAIMS THAT HE DEVELOPED A PRESSURE WOUND REQUIRING SURGERY DUE TO CUSHION GOING FLAT.
Patient problems: Pressure Sore/Ulcer
MAUDE report 20351792 ↗InjuryMay 2, 2023Use of Device Problem; Use of Device Problem
MEDICAL ASSISTANT CLAIMS PATIENT (END USER) DEVELOPED A PRESSURE INJURY DUE TO CUSHION GOING FLAT.
Patient problems: Pressure Sore/Ulcer
MAUDE report 16853338 ↗
Other Cushion, Flotation devices
- MEDLINE MSCBUB1818Medline Industries, Inc. · CUSHION, FLOTATION10 reports
- MEDLINE MSCBUB1818VLMedline Industries, Inc. · CUSHION, FLOTATION4 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
- ROHO HIGH PROFILE Single Compartment Cushion 1R109CRoho, 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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