DRIVEMEDICAL 15301CVRRecalls & reported problems
Drive Devilbiss Healthcare · Raw MaterialsTurning Product Description: Cover for 15301 · Class 1
All models of DRIVEMEDICAL (111)
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 00822383534411), received between Jan 14, 2026 and Jan 14, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Unintended Deflation” (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
- Unintended Deflation1
Patient problems
- Pressure Sore/Ulcer1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 14, 2026Unintended Deflation
DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A BARIATRIC MATTRESS. THE END USER REPORTED THAT THE MATTRESS HAS FAILED ON THREE OCCASIONS BY "BOTTOMING OUT," WHICH RESULTED IN THE DEVELOPMENT OF BED SORES REQUIRING HOME HEALTH WOUND CARE. ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. AS PART OF ITS COMPLAINT REVIEW AND EVALUATION PROCESS, DRIVE DEVILBISS HEALTHCARE WILL ALSO NOTIFY THE MANUFACTURER OF THE PRODUCT ABOUT THIS COMPLAINT.
Patient problems: Pressure Sore/Ulcer
MAUDE report 24071244 ↗
Other COVER, MATTRESS (MEDICAL PURPOSES) devices
- BED COVER-6X35X80-ZONE AIR-CAL117-NYLON BMC-52858-CRCF117-PCCurbell Medical Products, Inc. · Cover, Mattress (Medical Purposes)4 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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