DRIVEMEDICAL RTL12505Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00822383247151), received between Oct 8, 2018 and Jun 13, 2024 — classified as 15 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (8 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.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryJun 13, 2024Material Integrity Problem; Material Integrity Problem

  PER MDR #2438477-2024-00030: DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A BATH SEAT BY A PROVIDER, WHO REPORTED THE END USER WAS USING THE BATH SEAT WHEN THE CHAIR COLLAPSED. THE NATURE OF THE COLLAPSE HAS NOT BEEN SPECIFIED TO DATE. THE END USER WAS REPORTEDLY ADMITTED TO THE HOSPITAL WITH INJURIES CAUSED BY THE INCIDENT, HOWEVER, THE INJURIES HAVE NOT BEEN SPECIFIED TO DATE. DRIVE ATTEMPTED TO CONTACT THE PROVIDER ON SEVERAL OCCASIONS REGARDING THE INCIDENT AND THE PRODUCT, HOWEVER DID NOT RECEIVE ANY FURTHER INFORMATION. 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: Insufficient Information

  MAUDE report 19527056 ↗
• InjuryJun 12, 2024Fracture; Fracture

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A BATH SEAT BY A PROVIDER, WHO REPORTED THE END USER WAS USING THE BATH SEAT WHEN THE CHAIR COLLAPSED. THE NATURE OF THE COLLAPSE HAS NOT BEEN SPECIFIED TO DATE. THE END USER WAS REPORTEDLY ADMITTED TO THE HOSPITAL WITH INJURIES CAUSED BY THE INCIDENT, HOWEVER, THE INJURIES HAVE NOT BEEN SPECIFIED TO DATE. DRIVE ATTEMPTED TO CONTACT THE PROVIDER ON SEVERAL OCCASIONS REGARDING THE INCIDENT AND THE PRODUCT, HOWEVER DID NOT RECEIVE ANY FURTHER INFORMATION. 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: Insufficient Information

  MAUDE report 19522329 ↗
• InjuryMay 7, 2024Fracture; Fracture

  FROM DRIVE DEVILBISS MDR 2438477-2024-00023: DRIVE DEVILBISS WAS NOTIFIED OF AN INCIDENT INVOLVING A SHOWER CHAIR BY THE END USER'S WIFE WHO STATED THE SHOWER CHAIR SHATTERED WHILE IN USE. THE END USER FELL AND HIT HIS HEAD ON THE BACK OF THE TUB AND FELL ON HIS LEG STUMP CAUSING AN OPEN WOUND THAT REQUIRED ANTIBIOTICS. 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: Laceration(s)

  MAUDE report 19257904 ↗
• InjuryMay 6, 2024Fracture; Fracture

  DRIVE DEVILBISS WAS NOTIFIED OF AN INCIDENT INVOLVING A SHOWER CHAIR BY THE END USER'S WIFE WHO STATED THE SHOWER CHAIR SHATTERED WHILE IN USE. THE END USER FELL AND HIT HIS HEAD ON THE BACK OF THE TUB AND FELL ON HIS LEG STUMP CAUSING AN OPEN WOUND THAT REQUIRED ANTIBIOTICS. 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: Laceration(s)

  MAUDE report 19251867 ↗
• MalfunctionJul 27, 2023Break; Break

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A BATH BENCH BY A PROVIDER, WHO STATED THAT THE END USER "WAS SITTING ON THE CHAIR AND ONE LEG JUST SNAPPED." THE END USER REPORTEDLY UNDERWENT AN X-RAY SCAN WHICH REVEALED NO INJURY. 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 17404144 ↗
• InjuryJul 14, 2023Break; Break

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A BATH BENCH BY A PROVIDER, WHO STATED THAT THE END USER "WAS SITTING ON THE CHAIR AND ONE LEG JUST SNAPPED." THE END USER REPORTEDLY UNDERWENT AN X-RAY SCAN WHICH REVEALED NO INJURY. 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 17330372 ↗
• MalfunctionJul 5, 2023Collapse; Collapse

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A BATH BENCH BY AN END USER, WHO STATED THAT ONE OF THE LEGS OF THE UNIT "SNAPPED OFF," WHICH REPORTEDLY CAUSED HER TO "FALL OVER THE TUB" AND "[INJURE] ENTIRE RIGHT SIDE." THE END USER REPORTEDLY TREATED HER INJURY WITH ICE PACKS AND LIDOCAINE PATCHES. 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 17257041 ↗
• MalfunctionJun 27, 2023Collapse; Collapse

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A BATH BENCH BY AN END USER, WHO STATED THAT ONE OF THE LEGS OF THE UNIT "SNAPPED OFF," WHICH REPORTEDLY CAUSED HER TO "FALL OVER THE TUB" AND "[INJURE] ENTIRE RIGHT SIDE." THE END USER REPORTEDLY TREATED HER INJURY WITH ICE PACKS AND LIDOCAINE PATCHES. 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 17209749 ↗
• MalfunctionJun 27, 2023Collapse; Collapse

  DRIVE DEVILBISS HEALTHCARE RECEIVED A COMPLAINT INVOLVING A BATH CHAIR FROM AN END USER, WHO STATED THAT "THE LEG OF THE BATH CHAIR COLLAPSED, AND HE SUFFERED A STRAIN IN HIS THIGH MUSCLE." THE END USER DID NOT SEEK ANY MEDICAL TREATMENT. 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: Muscle/Tendon Damage

  MAUDE report 17209393 ↗
• InjuryApr 12, 2023Break; Break

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A STEERABLE KNEE WALKER BY AN END USERS' MOTHER, WHO REPORTED THAT THE KNEE PAD POST BROKE AND HER SON "FELL TO THE GROUND AND GOT HURT." 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 16723593 ↗
• InjurySep 24, 2022Collapse; Collapse

  (B)(6) HEALTHCARE WAS NOTIFIED ON AN INCIDENT INVOLVING A BATH SAFETY DEVICE ON (B)(6). WHILE USING THE UNIT THE PATIENT FELL IN BATHTUB EXACERBATING AN EXISTING BROKEN ANKLE. ON (B)(6) THE END-USER'S MOTHER REPORTED "MY SON WENT TO THE DOCTOR AND HAD A PLASTER CAST PUT ON HIS LEG AT THE APPOINTMENT THAT WE DISCUSSED, HOWEVER HE IS EXPERIENCING SOME FURTHER ISSUES AND HAS TO RETURN TO THE DOCTOR ON (B)(6) 2021 TO ADDRESS THE PAIN AND TRY TO FIND THE CAUSE OF THE INCREASED DIFFICULTY AT THIS TIME". THE PATIENT WAS PRESCRIBED TRAMADOL FOR PAIN. THE UNIT HAS NOT BEEN RETURNED FOR EVALUATION AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. DRIVE DEVILBISS HEALTHCARE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT AND INSPECT IT, AND WILL FILE AN UPDATE AS SOON AS ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Fall

  MAUDE report 15476402 ↗
• InjuryMar 2, 2022Collapse; Collapse

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED ON AN INCIDENT INVOLVING A BATH SAFETY DEVICE ON (B)(6). WHILE USING THE UNIT THE PATIENT FELL IN BATHTUB EXACERBATING AN EXISTING BROKEN ANKLE. ON (B)(6) THE END-USER'S MOTHER REPORTED "MY SON WENT TO THE DOCTOR AND HAD A PLASTER CAST PUT ON HIS LEG AT THE APPOINTMENT THAT WE DISCUSSED , HOWEVER HE IS EXPERIENCING SOME FURTHER ISSUES AND HAS TO RETURN TO THE DOCTOR ON (B)(6) 2021 TO ADDRESS THE PAIN AND TRY TO FIND THE CAUSE OF THE INCREASED DIFFICULTY AT THIS TIME ". THE PATIENT WAS PRESCRIBED TRAMADOL FOR PAIN. THE UNIT HAS NOT BEEN RETURNED FOR EVALUATION AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. DRIVE DEVILBISS HEALTHCARE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT AND INSPECT IT, AND WILL FILE AN UPDATE AS SOON AS ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Fall

  MAUDE report 13656724 ↗
• InjuryMar 2, 2022Fracture; Fracture

  FROM DRIVE DEVILBISS: DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A BATH SAFETY DEVICE. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. WE ARE FILING THIS REPORT IN AN OVERABUNDANCE OF CAUTION. A FOLLOW-UP SUBMISSION WILL BE FILED WHEN ADDITIONAL INFORMATION IS AVAILABLE. THE FRONT LEG OF THE BATH SAFETY DEVICE SNAPPED OFF WHILE IN USE. THE USER FELL ON HIS LEFT SIDE. WHEN HIS WIFE RETURNED HOME SHE TOOK HIM TO THE EMERGENCY ROOM. THEY TOOK X-RAYS AND DIAGNOSES MUSCLE TEARS. HE WAS PRESCRIBED PAIN MEDICINE AND STEROIDS.

  Patient problems: Fall; Muscle/Tendon Damage

  MAUDE report 13650176 ↗
• InjuryJan 21, 2022Break

  WHILE USING THE CHAIR IN THE SHOWER THE BACK LEG BROKE. THE USER FELL AND INJURED HIMSELF. HE SOUGHT MEDICAL ATTENTION AT THE EMERGENCY ROOM. THE RESULTS WERE INCONCLUSIVE. HE IS SUFFERING FROM LOWER BACK AND NECK PAIN.

  Patient problems: Fall; Pain

  MAUDE report 13318203 ↗
• InjuryNov 2, 2021Fracture; Fracture

  DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A BATH BENCH. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. WE ARE SUBMITTING THIS REPORT IN AN OVERABUNDANCE OF CAUTION AND TO BE TIMELY. WE WILL FILE A FOLLOW UP WHEN ADDITIONAL DATA BECOMES AVAILABLE. WHILE USING THE CHAIR IN THE SHOWER THE BACK LEG BROKE. THE USER FELL AND INJURED HIMSELF. HE SOUGHT MEDICAL ATTENTION AT THE EMERGENCY ROOM. THE RESULTS WERE INCONCLUSIVE. HE IS SUFFERING FROM LOWER BACK AND NECK PAIN.

  Patient problems: Neck Pain

  MAUDE report 12741812 ↗
• InjuryOct 21, 2021Fracture; Fracture

  (B)(4) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A BATH SAFETY DEVICE. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. WE ARE FILING THIS REPORT IN AN OVERABUNDANCE OF CAUTION. A FOLLOW-UP SUBMISSION WILL BE FILED WHEN ADDITIONAL INFORMATION IS AVAILABLE. THE FRONT LEG OF THE BATH SAFETY DEVICE SNAPPED OFF WHILE IN USE. THE USER FELL ON HIS LEFT SIDE. WHEN HIS WIFE RETURNED HOME SHE TOOK HIM TO THE EMERGENCY ROOM. THEY TOOK X-RAYS AND DIAGNOSES MUSCLE TEARS. HE WAS PRESCRIBED PAIN MEDICINE AND STEROIDS.

  Patient problems: Fall; Muscle/Tendon Damage

  MAUDE report 12678192 ↗
• InjuryMay 4, 2020Fracture; Fracture

  DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A BATH SEAT. NOTICE OF THE INCIDENT WAS TENDERED BY LEGAL ENTITY. WE HAVE ARE AWAITING ACCESS TO THE PRODUCT FOR EVALUATION. THE END-USER WAS SITTING ON THE DEVICE WHILE BATHING WHEN IT REPORTEDLY BROKE. SHE LANDED ON HER AMPUTATION. A FRACTURE WAS DIAGNOSED IN THE NUB REQUIRING SURGICAL INTERVENTION.

  Patient problems: Bone Fracture(s)

  MAUDE report 10021804 ↗
• InjuryApr 1, 2019Material Fragmentation; Material Fragmentation

  (B)(4) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A SHOWER CHAIR. THE END-USER DISCARDED THE CHAIR. THERE ARE NO PICTURES OF THE DEVICE. (B)(4) WILL BE UNABLE TO EVALUATE THE DEVICE. THE DEVICE WAS PURCHASED 3 MONTHS BEFORE IT BROKE. IT REQUIRED ASSEMBLY. IT WAS ADJUSTABLE FOR HEIGHT AND HAD GRIPS FOR THE FLOOR. END-USER CLAIMED THAT THE SHOWER CHAIR BROKE IN HALF FROM SIDE TO SIDE AND SHATTERED. THE BROKEN PLASTIC INJURED HIS HIP. THE END-USER WENT TO HIS THERAPIST AFTER THE INCIDENT. END-USER IS PARALYZED ON HIS LEFT SIDE SDE DUE TO A STROKE.

  Patient problems: Fall

  MAUDE report 8471388 ↗
• InjuryOct 8, 2018Fracture; Fracture

  (B)(4) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A BATH CHAIR. THE DEVICE WAS DISCARDED BY THE END-USER. SHE PROVIDED PHOTOS. THE END-USER WAS SHOWERING. SHE WAS ABOUT TO GET UP WHEN THE FRONT RIGHT LEG CRACKED CAUSING HER TO FALL FORWARD ONTO THE FAUCET. SHE DID NOT SEEK MEDICAL ATTENTION. AT THE TIME OF THE INCIDENT HER ANKLE HAD BEEN DIAGNOSED WITH A SPRAIN. AFTER THE INCIDENT SHE WAS DIAGNOSED WITH A BROKEN FIBULA. SHE IS NOT SURE IF THE FIBULA WAS BROKEN BEFORE OR DURING THE INCIDENT.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 7942657 ↗