Drive 11135-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00822383102214), received between Sep 15, 2020 and Jan 26, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Material Separation” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 26, 2023Material Separation; Material Separation

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A COMMODE BY AN END USER, WHO STATED THAT "WHILE USING IT CLOSER TO THE FRONT EDGE, THE SEAT POPPED OFF THE BACK OF THE FRAME AND SHE FELL." THE END USER REPORTEDLY SUSTAINED A HAIRLINE FRACTURE TO HER LEFT FEMUR. 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; Limb Fracture

  MAUDE report 16248885 ↗
• InjurySep 26, 2022Material Integrity Problem; Material Integrity Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A COMMODE BY THE END USER'S HUSBAND, WHO REPORTED THAT "THE LEG BROKE WHILE SHE GOT UP AND SPRAINED HER WRIST," "HURT HER LEFT LEG," AND "ALSO LANDED ON HER HEAD." 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; Head Injury

  MAUDE report 15484953 ↗
• InjuryAug 11, 2021Material Separation; Material Separation

  DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A COMMODE. WE HAVE NOT RECEIVED THE DEVICE FOR EVALUATION. WE WILL FILE A FOLLOW-UP AS INFORMATION IS AVAILABLE. THE SEAT TO THE CHAIR WAS NOT FIXED TO THE FRAME, THE MOLDING OF THE CHAIR JUST CLIPS OVER THE FRAME. SO A PATIENT TIPPED FORWARD IN THE CHAIR TO ADJUST AND THE SEAT OF THE CHAIR LIFTED OFF THE OF THE FRAME. THE PATIENT FELL FORWARD AND HIT HER HEAD ON THE WALL CAUSING INJURY.

  Patient problems: Fall; Head Injury

  MAUDE report 12309702 ↗
• InjurySep 15, 2020Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A BARIATRIC COMMODE. THIS REPORT IS IN RESPONSE TO A MEDWATCH REPORT (B)(4). THE FOLLOWING IS A VERBATIM ACCOUNT OF THE EVENT FROM THE INVESTIGATION. THE INCIDENT OCCURED IN A HOSPITAL. AN ATTENDANT WAS ASSISTING THE PATIENT TO THE COMMODE. THE ATTENDANT BRIEFLY LEFT THE ROOM AND HEARD A LOUD CRASH. UPON RETURNING, THE ATTENDANT SAW THE PATIENT ON THE FLOOR AND THE LEFT ARM OF THE COMMODE BENT. THE PATIENT MAY HAVE BRIEFLY SAT ON THE ARM TO ADJUST THEMSELVES AND THE ARM BENT. THE ATTENDANT WAS ALSO NOT SURE IF THE PIN IN THE ARM WAS FULLY EXTENDED. THE FACILITY DID NOT ASK THE PATIENT ANY QUESTIONS AFTER THE INCIDENT AS HE WAS "OUT OF IT." THE PATIENT FRACTURED THE BASE OF HIS RIGHT THUMB, WHICH REQUIRED SURGERY, AND HAD A LACERATION ABOVE THE LEFT EYE, WHICH WAS APPROXIMATELY 2-3 CM IN LENGTH. IT IS CURRENTLY UNKNOWN IF STITCHES WERE NEEDED. WE HAVE REQUESTED PHOTOS OF THE PRODUCT AND WILL BE DISCUSSING THE RETURN OF THE COMMODE WITHIN OUR COVID-19 PROTOCOLS. A WARNING LABEL IS REQUIRED ON THE ARM OF THE COMMODE. THE LABEL IS 3" X 1" WITH A BLACK BACKGROUND AND YELLOW LETTERING WITH A WARNING ICON. THE REQUI

  Patient problems: Bone Fracture(s); Fall; Laceration(s)

  MAUDE report 10538773 ↗