MEDLINE MSCBUB1818Recalls & reported problems
Medline Industries, Inc. · CUSHION,PRE-INFLATED,BUBBLE,18X18 · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888277720049), received between Sep 7, 2026 and Sep 30, 2026 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (4 reports).
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
- Gas/Air Leak4
- Material Split, Cut or Torn3
- Deflation Problem2
- Material Puncture/Hole1
- Unintended Deflation1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Gas/Air Leak
It was reported that "IT HAS A LEAK."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948233 ↗MalfunctionSep 30, 2026Material Split, Cut or Torn
It was reported that the replacement cushion sprung a small leak.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946360 ↗MalfunctionSep 28, 2026Gas/Air Leak; Material Split, Cut or Torn
It was reported that "air bubbling from one of the seams in the cushion holes."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913606 ↗MalfunctionSep 28, 2026Material Puncture/Hole
It was reported that "THERE IS A SMALL HOLE IN THE PRODUCT CAUSING IT TO LEAK."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913452 ↗MalfunctionSep 24, 2026Gas/Air Leak
It was reported that "I've seen 3 almost flat air cushions over the last couple of weeks."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50886178 ↗MalfunctionSep 10, 2026Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50717694 ↗MalfunctionSep 9, 2026Deflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50693755 ↗MalfunctionSep 8, 2026Unintended Deflation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50673285 ↗MalfunctionSep 8, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50671757 ↗MalfunctionSep 7, 2026Deflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50655327 ↗
Other CUSHION, FLOTATION devices
- 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
- ROHO HIGH PROFILE Single Compartment Cushion 1R109CRoho, 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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