Aquasence 770-525Recalls & reported problems
Drive Devilbiss Healthcare · Bath SafetyBenches/Stools Product Description: AQS FOLD BATH SEAT, WHITE, 1EA, 2CV,Ret · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00754021210336), received between Dec 20, 2019 and Aug 25, 2024 — classified as 4 injuries.
The most frequently reported specific device problem is “Break” (3 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
- Material Fragmentation1
Patient problems
- Laceration(s)2
- Limb Pain2
- Muscle Weakness/Atrophy2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryAug 25, 2024Break; Break
DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A BATH SEAT BY THE END USER'S SON WHO STATED THE DEVICE'S SEAT BROKE CAUSING THE END USER TO FALL. THE END USER LEGS ARE WEAK AND PAINFUL. THE END USER IS HAVING DIFFICULTY WALKING. 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: Limb Pain; Muscle Weakness/Atrophy
MAUDE report 20059741 ↗InjuryAug 22, 2024Break; Break
DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A BATH SEAT BY THE END USER'S SON WHO STATED THE DEVICE'S SEAT BROKE CAUSING THE END USER TO FALL. THE END USER LEGS ARE WEAK AND PAINFUL. THE END USER IS HAVING DIFFICULTY WALKING. 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: Limb Pain; Muscle Weakness/Atrophy
MAUDE report 20044029 ↗InjuryFeb 17, 2020Break
DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A BATH BENCH. PRODUCT HAS NOT BEEN RECOVERED FOR EVALUATION. END-USER WAS SITTING ON THE CHAIR IN THE SHOWER. THE BACK REPORTEDLY BROKE OFF. SHE SUSTAINED A LACERATION. NO FURTHER DETAILS ARE AVAILABLE. WE ARE REPORTING THIS EVENT IN AN OVERABUNDANCE OF CAUTION.
Patient problems: Laceration(s)
MAUDE report 9716662 ↗InjuryDec 20, 2019Material Fragmentation; Material Fragmentation
DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A BATH BENCH. PRODUCT HAS NOT BEEN RECOVERED FOR EVALUATION. END-USER WAS SITTING ON THE CHAIR IN THE SHOWER. THE BACK REPORTEDLY BROKE OFF. SHE SUSTAINED A LACERATION. NO FURTHER DETAILS ARE AVAILABLE. WE ARE REPORTING THIS EVENT IN AN OVERABUNDANCE OF CAUTION.
Patient problems: Laceration(s)
MAUDE report 9501043 ↗
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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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