DRIVEMEDICAL 12202KD-4Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 50822383222061), received between Mar 21, 2019 and Jun 20, 2023 — classified as 3 injuries, 1 malfunction.

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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2023Collapse; Collapse

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A BATH BENCH BY A PROVIDER, WHO STATED THAT THE LEGS OF THE UNIT "BENT WHILE CUSTOMER WAS SITTING ON IT, CUSTOMER FELL FROM CHAIR." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR 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 17166735 ↗
• InjuryMar 29, 2023Device Tipped Over; Device Tipped Over

  DRIVE DEVILBISS HEALTHCARE RECEIVED A COMPLAINT INVOLVING A BATH CHAIR FROM A HEALTHCARE PROVIDER, WHO STATED THAT THERE HAD BEEN "THREE FALLS WITH INJURY " IN THEIR HOSPITAL. UPON INVESTIGATION, IT WAS REVEALED THAT THE FIRST INCIDENT WAS NOT A FALL AND DID NOT INVOLVE AN INJURY; THE SECOND INCIDENT WAS NOT A FALL AND DID NOT INVOLVE AN INJURY, BUT RATHER A REPORT THAT A CHAIR "TIPPED TO THE LEFT" WHILE A PATIENT WAS LEANING TO THE LEFT SIDE; AND THE THIRD INCIDENT INVOLVED A PATIENT WHO "LEANED OVER TOO FAR" AND FELL, SUSTAINING A LACERATION TO HER LIP." ALL THREE CHAIRS WERE CONFIRMED DISCARDED, SO DRIVE CANNOT RETRIEVE THEM FOR EVALUATION.

  Patient problems: Fall; Laceration(s)

  MAUDE report 16640044 ↗
• InjuryDec 8, 2020Material Fragmentation; Material Fragmentation

  DRIVE DEVILBISS HEALTHCARE IS THE INITIAL AL IMPORTER OF THE DEVICE WHICH IS A SHOWER CHAR. WE ARE FILING THIS REPORT IN AN OVER-ABUNDANCE OF CAUTION DUE TO AN MDR REGRESSION ANALYSIS. THE UNIT WAS NOT RETURNED FOR EVALUATION. WHILE USING THE DEVICE IN THE SHOWER THE LEG BROKE, THE END-USER FELL AND HIT HER HEAD ON THE SINK. SHE WENT TO THE DOCTOR. NO SERIOUS INJURIES WERE SUSTAINED HOWEVER, SHE ATTENDED THERAPY AND STOPPED DUE TO A SWOLLEN KNEE. SINCE THE DEVICE WAS NOT RETURNED AND PICTURES NOT PROVIDED A ROOT CAUSE COULD NOT BE ASCERTAINED. HISTORICAL DATA OF COMPLAINTS OF THE SAME NATURE WERE REVIEWED AND FOUND VERY LIMITED REPORTING AND A FOUR PERCENT DEFECT RATE OVER TWO YEARS.

  Patient problems: Fall

  MAUDE report 10968812 ↗
• InjuryMar 21, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A BATH CHAIR. THE CHAIR WAS PROVIDED TO HIM BY THE HOTEL HE WAS VISITING. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IT IS UNCLEAR IF THE DEVICE BROKE OR WAS NOT SET UP PROPERLY. THIS IS A LEGAL CLAIM. THE END-USER IS AN AMPUTEE. THE RIGHT SIDE LEGS GAVE OUT AS HE WAS USING THE CHAIR IN THE SHOWER. HE FELL. HIS STUMP HIT THE SHOWER GRATE BAR CAUSING BRUISING AND MINOR ABRASIONS. HE HURT HIS LEFT HIP AND ELBOW. HE WAITED TWO DAYS TO SEEK MEDICAL ATTENTION DUE TO EMBARRASSMENT. HE WENT TO THE VA WHERE THEY CHECKED THE STUMP FOR INFECTION. HE WENT TO PHYSICAL THERAPY FOR THE PAIN IN HIS HIP.

  Patient problems: Bruise/Contusion; Fall

  MAUDE report 8441996 ↗