Hugo 700-959E (UDI 00754021210602)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00754021210602), received between Oct 17, 2018 and Nov 27, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Fracture” (3 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.

• InjuryNov 27, 2023Misassembled During Installation; Misassembled During Installation

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT BY THE END USER OF THE ROLLATOR BEING ASSEMBLED INCORRECTLY. THE END USER ASSEMBLED THE LEGS AND HANDLEBARS ON THE INCORRECT SIDE AND BACKWARDS. THIS CAUSED THE BRAKES TO CUT HER LEGS. THE WOUND BECAME INFECTED AND THE DOCTOR PRESCRIBED ANTIBIOTICS. THE END USER WAS EDUCATED BY DRIVE DEVILBISS CUSTOMER SOLUTIONS ON THE PROPER INSTALLATION OF THE LEGS AND HANDLEBARS. THE END USER REALIZED HER MISTAKE IN ASSEMBLY OF THE DEVICE. AN UPDATE WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Laceration(s)

  MAUDE report 18210454 ↗
• InjuryJul 11, 2022Fracture; Fracture

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY AN END USER, WHO REPORTED THAT THE HANDLE CRACKED OFF, CAUSING A VERY SHARP EDGE THAT CUT HER LEG, WHICH REQUIRED HER TO GET STITCHES IN THE EMERGENCY ROOM. THE END USER'S MOTHER REPORTED THAT THE END USER IS UNSURE IF THE FALL WAS CAUSED BY THE BROKEN HANDLE, OR IF THE HANDLE WAS BROKEN AS A RESULT OF THE FALL. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT AND EVALUATE IT, AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Laceration(s)

  MAUDE report 14977203 ↗
• InjuryOct 26, 2021Fracture; Fracture

  (B)(4) HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. WE ARE FILING THIS REPORT TO BE TIMELY AND IN AN OVERABUNDANCE OF CAUTION. WE FILL SUBMIT A FOLLOW-UP IF ADDITIONAL INFORMATION BECOMES AVAILABLE. WHILE IN USE THE REAR WHEEL BRAKE ON THE RIGHT SIDE DID NOT ENGAGE. HE FELL AND SUSTAINED MULTIPLE ABRASIONS. HE WENT TO THE DOCTOR FOR TREATMENT.

  Patient problems: Abrasion

  MAUDE report 12696911 ↗
• InjuryMay 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. OUR POST MARKET ASSOCIATE HAS BEEN ATTEMPTING TO COLLECT DATA REGARDING THIS INCIDENT BUT HAS BEEN UNABLE TO REACH THE END-USER, END-USER FELL OFF ROLLATOR AND BROKE HER HIP. SHE IS IN A NURSING HOME RECEIVING PHYSICAL THERAPY DUE TO THE INJURY. IT IS UNKNOWN HOW SHE FELL. THERE IS NO INDICATION OF PRODUCT ISSUE. WE ARE FILING A REPORT IN AN OVERABUNDANCE OF CAUTION. THIS REPORT WILL BE UPDATED BY FOLLOWUP SUBMISSION WHEN INFORMATION BECOMES AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 8623728 ↗
• InjuryNov 12, 2018Fracture; Fracture

  DRIVE DEVILBISS IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. THE SERIAL NUMBER FORMAT SUGGESTS THAT THIS ITERATION OF THE DEVICE WAS MADE FOR AMG MEDICAL. DRIVE WAS INFORMED OF THE EVENT WITH THE RECEIPT OF A LEGAL SUMMONS. WE DO NOT ANTICIPATE BEING ABLE TO RETRIEVE THE UNIT FOR EVALUATION. THE ENDUSER WAS NAVIGATING THROUGH A MUSEUM USING THE DEVICE. HE SAT DOWN TO SPEAK TO THE TOUR GUIDE WHEN THE WALKER FRAME REPORTEDLY SNAPPED. THE USER FELL LANDING ON HIS RIGHT HIP AND HEAD. HE WAS TAKEN TO THE EMERGENCY ROOM. HE WAS DIAGNOSED WITH A FRACTURED HIP AND WAS IMMEDIATELY TAKEN TO SURGERY. HE WAS TREATED AT A SPECIALIZED FACILITY AND RETURNED HOME AFTER APPROXIMATELY 3 MONTHS. IT IS REPORTED THAT HE SUFFERED HEARING LOSS FROM THE INCIDENT.

  Patient problems: Fall; Head Injury; Hip Fracture

  MAUDE report 8059289 ↗
• InjuryOct 17, 2018Break

  (B)(4) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. THE SERIAL NUMBER FORMAT SUGGESTS THAT THIS ITERATION OF THE DEVICE WAS MADE FOR AMG MEDICAL. "DRIVE" WAS INFORMED OF THE EVENT WITH THE RECEIPT OF A LEGAL SUMMONS. WE DO NOT ANTICIPATE BEING ABLE TO RETRIEVE THE UNIT FOR EVALUATION. THE END USER WAS NAVIGATING THROUGH A MUSEUM USING THE DEVICE. HE SAT DOWN TO SPEAK TO THE TOUR GUIDE WHEN THE WALKER FRAME REPORTEDLY SNAPPED. THE USER FELL LANDING ON HIS RIGHT HIP AND HEAD. HE WAS TAKEN TO THE EMERGENCY ROOM. HE WAS DIAGNOSED WITH A FRACTURED HIP AND WAS IMMEDIATELY TAKEN TO SURGERY. HE WAS TREATED AT A SPECIALIZED FACILITY AND RETURNED HOME AFTER APPROXIMATELY 3 MONTHS. IT IS REPORTED THAT HE SUFFERED HEARING LOSS FROM THE INCIDENT.

  Patient problems: Fall; Hearing Loss; Hip Fracture

  MAUDE report 7973963 ↗