ROHO Hybrid Select Cushion HS1517CRecalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613732109134), received between Aug 14, 2026 and Aug 14, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- Pressure Sore/Ulcer1
- Tissue Breakdown1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
User reported to Spinlife that she had been hospitalized due to a pressure injury on her left buttock.She was also in the hospital for 2 days receiving meds for the infection. The sore will not heal and she is still working with wound care to try to get it under control to some extent. The wound was initially observed on (b)(6) 2026 but not reported to ROHO, Inc. until 7/13/2026. User reported too Spinlife her Phhysical Therapist had added air to her cushion but she did not know if it had been inflated properly.Spinlife has not provided end user information for additional follow up information.
Patient problems: Pressure Sore/Ulcer; Tissue Breakdown
MAUDE report 50262989 ↗
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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