DRIVEMEDICAL 12486Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00822383108902), received between Mar 27, 2019 and Jul 20, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Break” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 20, 2023Break; Break

  (B)(6) WAS NOTIFIED OF A COMPLAINT REGARDING A BATH BENCH BY AN INSURANCE CLAIMS REPRESENTATIVE ON BEHALF OF THE PROPERTY WHERE THE ACCIDENT OCCURRED. THE REPRESENTATIVE STATED THAT THE END USER "WAS INJURED WHEN THE HANDICAP BATHROOM BENCH FAILED, CAUSING HER TO FALL TO THE GROUND." THERE WERE NO ADDITIONAL DETAILS AS TO THE NATURE OF THE INJURY OR PRODUCT MALFUNCTION. THERE WAS NO REPORT OR EVIDENCE OF MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. 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 17360992 ↗
• InjuryApr 21, 2023Collapse; Collapse

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SHOWER STOOL BY AN END USER, WHO STATED THAT SHE WAS "SITTING ON IT AND IT SUDDENLY COLLAPSED WITH [HER] ON IT, CAUSING A FALL AND SOME BRUISES." THE END USER REPORTED THAT UPON INSPECTION, "TWO OF THE BOLTS USED TO HOLD THE STATIONARY LEG OF THE STOOL ARE NOT THERE AT ALL." THE END USER DID NOT SEEK ANY MEDICAL TREATMENT AS A RESULT OF THE INCIDENT. MULTIPLE ATTEMPTS TO GATHER FURTHER INFORMATION HAVE BEEN MADE, AND TO RETRIEVE THE PRODUCT FOR EVALUATION, BUT DRIVE HAS NOT RECEIVED A RESPONSE. DRIVE WILL CONTINUE TO MONITOR COMPLAINTS FOR ANY RELATED TRENDS.

  Patient problems: Bruise/Contusion; Fall

  MAUDE report 16788509 ↗
• InjurySep 12, 2022Break; Break

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A BATH BENCH BY AN END USER, WHO REPORTED THAT "SHE WAS SITTING ON THE CHAIR, AND THE LEG SNAPPED. SHE HIT HER LOWER BACK, AND HIP, AND BOTTOM IS VERY BLACK AND BLUE." SHE WENT TO THE EMERGENCY ROOM AND RECEIVED AN MRI AND X-RAY FOR HER TAILBONE. 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 15406602 ↗
• InjuryApr 13, 2022Fracture; Fracture

  ON FEBRUARY 8, 2022, (B)(4) HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A BATH BENCH. THE END USER'S HUSBAND STATED THAT THE CHAIR "HAD A CATASTROPHIC FAILURE" AND SUBMITTED ONE CLOSE-UP PHOTOGRAPH THAT SEEMS TO DEPICT THE UNDERSIDE OF THE BENCH AT THE POINT WHERE ONE OF THE LEGS WOULD CONNECT WITH THE SEAT, WHICH APPEARS TO HAVE BEEN RIPPED OUT IN SOME UNKNOWN MANNER. THE REPORTER STATED THAT THE FAILURE "CRUSHED HER LEG IN THE PROCESS," AND LATER CONFIRMED THAT SHE SOUGHT MEDICAL ATTENTION AND WAS TREATED FOR A SPRAIN AND BRUISES WITH IBUPROFEN. THE CHAIR WAS DISCARDED AND THEREFORE CANNOT BE RETURNED FOR EVALUATION.

  Patient problems: Fall; Insufficient Information

  MAUDE report 14105644 ↗
• No answer providedNov 29, 2021No Apparent Adverse Event; No Apparent Adverse Event

  (B)(4) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS BATH SAFETY /SHOWER STOOL. WE ARE FILING THIS SUBMISSION IN RESPONSE TO MW5104731. THIS MEDWATCH REPORT INCORRECTLY CLASSIFIES THIS AS A SERIOUS INJURY. THERE WAS NO ADVERSE EVENT AND NO INJURY SUSTAINED. THE USER HAS ADVISED THAT THERE IS A POTENTIAL DESIGN ISSUE WE PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. THIS INFORMATION IS BEING INVESTIGATED BY THE POST MARKET SURVEILLANCE TEAM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12882266 ↗
• InjuryMar 27, 2019Material Fragmentation; Material Fragmentation

  (B)(4) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A BATH BENCH. THE DEVICE WAS IN USE BY THE END-USER FOR A YEAR. PMS DOES NOT ANTICIPATE RETURN OF THE DEVICE FOR EVALUATION. PATIENT REQUIRES COMPENSATION. THE END-USER WAS SITTING ON CHAIR IN HIS SHOWER AND THE CHAIR COLLAPSED. THE BRACKET CONNECTING THE SEAT TO THE LEGS HAD FAILED. HIS NECK AND BACK HIT THE WALL. HE INJURED HIS TAILBONE. PHYSICAL THERAPY AND A CHIROPRACTOR WAS REQUIRED. HE NOTED THAT THE DEVICE WAS STORED IN A DRY AREA OF THE BATHROOM.

  Patient problems: Fall; Pain

  MAUDE report 8458364 ↗