MEDLINE NON081147Recalls & reported problems
Medline Industries, Inc. · POSITIONER,COMFORT TOUCH,2-LYR,28CS · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10080196413256), received between Sep 4, 2026 and Sep 30, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Unfold or Unwrap” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Unfold or Unwrap1
- Inflation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Failure to Unfold or Unwrap
It was reported that "They are not expanding as they should."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949271 ↗MalfunctionSep 4, 2026Inflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50617901 ↗
Other SUPPORT, PATIENT POSITION devices
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- DeRoyal 8000HDPDeroyal Industries, Inc. · SUPPORT, PATIENT POSITION16 reports
- PILLOW, GENTLETOUCH, 7 INCH RT 1937Mizuho Orthopedic Systems, Inc. · Support, Patient Position11 reports
- Battalion 27428Alphatec Spine, Inc. · SUPPORT, PATIENT POSITION3 reports
- Medline MSC50023Medline Industries, Inc. · SUPPORT, PATIENT POSITION2 reports
- Olympic Vac-Pac Size 30Natus Medical Incorporated · Support, Patient Position2 reports
- ACUFEX 72205103Smith & Nephew, Inc. · SUPPORT, PATIENT POSITION2 reports
- Berkette Beach Chair Limb Positioner 711200Aspen Surgical Products, Inc. · SUPPORT, PATIENT POSITION2 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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