DRIVEMEDICAL 11148CE-4Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 50822383901287), received between May 15, 2020 and Aug 2, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Component Missing” (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.

• InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A COMMODE BY AN END USER'S SISTER, WHO REPORTED THAT THE END USER FELL WHILE SUPPORTING HERSELF ON THE COMMODE ARMRESTS AND SUSTAINED A BROKEN THUMB AND FEMUR, AS WELL AS SOME BRUISING. THE END USER REPORTED TREATING HER INJURIES AT A HOSPITAL. REPEATED ATTEMPTS TO HAVE THE DEVICE RETURNED FOR INVESTIGATION WERE UNSUCCESSFUL. DRIVE BELIEVES THEY WILL BE UNABLE TO GATHER ADDITIONAL INFORMATION. DRIVE IS SUBMITTING A FINAL REPORT AT THIS TIME. IF PERTINENT INFORMATION BECOMES AVAILABLE TO DRIVE AT A LATER DATE, AN ADDENDUM TO THIS REPORT WILL BE FILED.

  Patient problems: Bruise/Contusion; Fall; Multiple Fractures

  MAUDE report 17442799 ↗
• InjuryOct 12, 2021Component Missing; Component Missing

  (B)(4) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A COMMODE. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. WE ARE FILING THIS REPORT IN AN OVERABUNDANCE OF CAUTION. WE WILL SUBMIT A FOLLOW-UP WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. THE END-USER FELL WHILE USING THE DEVICE IN THE SHOWER. IT WAS NOTED THAT THE DEVICE WAS MISSING A SCREW. THE CAREGIVER TRIED TO BREAK HER FALL SINCE SHE IS A SMALL FRAME PERSON. THE CAREGIVER CALLED HER GRANDDAUGHTER TO THE BATHROOM TO HELP LIFT THE USER WHO WAS COMPLAINING THAT HER HEAD WAS HURTING. SHE WAS TAKEN TO THE EMERGENCY ROOM. THEY TOOK A CT SCAN AND GAVE HER MEDICINE.

  Patient problems: Fall; Head Injury

  MAUDE report 12617523 ↗
• InjuryFeb 12, 2021Solder Joint Fracture; Solder Joint Fracture

  DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A COMMODE. THE DEVICE IS UNAVAILABLE FOR EVALUATION AS IT HAS BEEN DISCARDED BY THE END-USER. A PICTURE WAS SUPPLIED OF THE ISSUE. WE ARE REPORTING THIS INCIDENT IN AN OVERABUNDANCE OF CAUTION. COMMODE CHAIR FAILED AT THE WELDS. THE END-USER WAS SITTING ON THE TOILET BOWL AND THE WELD BROKE. THE TOILET SEAT FELL THROUGH AND THE END-USER FELL TO THE GROUND. END-USER BELIEVES THE FALL EXACERBATED THE INJURY. HIS KNEE IS NOW SWOLLEN AND ACHY. DUE TO COVID MEDICAL TREATMENT HAS NOT BEEN SOUGHT.. HE HAD A VIDEO CALL WITH HIS DOCTOR ADVISED HIM TO TAKE 2 - 4 TYLENOL A DAY. HE HAS BEEN ICING HIS KNEE.

  Patient problems: Bruise/Contusion; Fall

  MAUDE report 11324695 ↗
• InjuryMay 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A FOLDING COMMODE. THE COMMODE HAS NOT BEEN RETURNED FOR EVALUATION. AN ADVERSE EVENT HAS OCCURED WITHOUT PRODUCT ISSUE. END-USER WAS TRANSFERRING FROM WHEELCHAIR TO COMMODE WHEN THE COMMODE TIPPED. THE END-USER FELL AND HIT HIS HEAD. NO STITCHES REQUIRED. THERE WAS BRUSING OF HIS STUMP.

  Patient problems: Fall; Laceration(s)

  MAUDE report 10063331 ↗