Drive RTL12061MRecalls & reported problems
Drive Devilbiss Healthcare · Swivel Seat Stool, 1 RTL, 4/CS · Class 1
Data updated Oct 13, 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 00822383541921), received between Oct 14, 2022 and Nov 4, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Collapse” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Collapse1
- Material Integrity Problem1
Patient problems
- Fall2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 4, 2022Collapse; Collapse
DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SWIVEL SEAT SHOWER STOOL BY AN END USER, WHO STATED "THE PLASTIC PART OF UPPER LEG BROKE AWAY, SPLIT AT SEAM," CAUSING HER TO FALL IN THE TUB. PARAMEDICS WERE CALLED FOR LIFT ASSIST, BUT SHE DID NOT SUSTAIN ANY INJURIES THAT WARRANTED TRANSPORT TO THE HOSPITAL. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT AND INSPECT IT, AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Patient problems: Fall
MAUDE report 15732993 ↗MalfunctionOct 14, 2022Material Integrity Problem; Material Integrity Problem
DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SWIVEL SEAT SHOWER STOOL BY AN END USER, WHO STATED "THE PLASTIC PART OF UPPER LEG BROKE AWAY, SPLIT AT SEAM," CAUSING HER TO FALL IN THE TUB. PARAMEDICS WERE CALLED FOR LIFT ASSIST, BUT SHE DID NOT SUSTAIN ANY INJURIES THAT WARRANTED TRANSPORT TO THE HOSPITAL. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT AND INSPECT IT, AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Patient problems: Fall
MAUDE report 15605898 ↗
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- Drive RTL12203KDRDrive Devilbiss Healthcare · ADAPTOR, HYGIENE9 reports
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- Aquasence 770-525Drive Devilbiss Healthcare · ADAPTOR, HYGIENE4 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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