ROHO HIGH PROFILE Single Compartment Cushion 1R109CRecalls & reported problems
Roho, Inc. · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613732005481), received between Feb 27, 2023 and Apr 17, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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
- Improper or Incorrect Procedure or Method1
- Mechanical Problem1
Patient problems
- Pressure Sore/Ulcer1
- Skin Erosion1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 17, 2025Mechanical Problem; Mechanical Problem
USER REPORTED THE END OF THE VALVE WAS MISSING. USER STATED SHE KEEPS GETTING PRESSURE ULCERS BUT STATE "WON'T SAY THAT THE CUSHION CAUSED THE ULCERS". THE USER HAS BEEN PLACED ON BEDREST, THE IMPROPERLY INFLATED CUSHION EXACERBATED HER EXISTING PRESSURE INJURY. THE CUSHION WAS RETURNED TO ROHO AND VERIFIED TO HAVE A MISSING VALVE ON (B)(6) 2025.
Patient problems: Skin Erosion
MAUDE report 21853096 ↗InjuryFeb 27, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
CUSOMER CLAIMS THAT HE DEVELOPED A PRESSURE WOUND DUE TO CUSHION GOING FLAT.
Patient problems: Pressure Sore/Ulcer
MAUDE report 16444058 ↗
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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