Drive SFPRO317FS-21Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00822383991771), received between Nov 17, 2021 and Feb 22, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 22, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT BY THE PROVIDER THAT AN END USER WAS USING A MOTORIZED SCOOTER IN A PARKING LOT WHEN THE DEVICE WENT OVER A "CONCAVE" BUMP AND THE ENTIRE UNIT FELL OVER. THE END USER'S LEG WAS SCRATCHED/CUT. THE WOUNDS BECAME INFECTED AND THE USER WAS ADMITTED TO THE HOSPITAL FOR CELLULITIS. THE DEVICE IS BEING RETURNED FOR EVALUATION. AN UPDATE WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Cellulitis

  MAUDE report 18758653 ↗
• InjuryMay 8, 2023Device Slipped; Device Slipped

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF A COMPLAINT REGARDING A POWER SCOOTER BY AN END USER WHO STATED THAT JUST AFTER HE HAD "ADJUSTED THE SEAT AS IT WAS TOO HIGH," HE WAS BEING TRANSPORTED AND "THE SEAT SLID COMPLETELY OFF THE SCOOTER BODY." IT IS UNCLEAR HOW THE END USER WAS BEING TRANSPORTED. THE END USER REPORTEDLY SUSTAINED INJURIES TO HIS SHOULDER AND AGGRAVATED AN ALREADY BAD HIP AS A RESULT OF THE INCIDENT, AND SOUGHT TREATMENT IN THE EMERGENCY ROOM. 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: Damage to Ligament(s)

  MAUDE report 16887076 ↗
• InjuryOct 10, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A POWER SCOOTER BY AN END USER'S SISTER, WHO STATED THAT THE END USER "TRIED TO GET ONTO THE SCOOTER AND MUST HAVE TRIED TO HOLD ON BY THE THROTTLE AND IT MOVED ON HER," CAUSING HER TO FALL AND INJURE HER LEG. SHE WAS REPORTEDLY HOSPITALIZED FOR 3 DAYS AND IS NOW UNDERGOING PHYSICAL THERAPY. 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 15574262 ↗
• InjuryOct 10, 2022Break; Break

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A POWER SCOOTER BY A DISTRIBUTOR, WHO STATED THAT "THE PATIENT WAS ON A BUS," INTO WHICH "THE SCOOTER WAS BUCKLED IN." THE END USER REPORTED THAT THE SEAT SLID OFF THE SCOOTER, CAUSING HER TO FALL AND BECOME INJURED. SHE REPORTED PAIN IN HER HIP AND A SORE ARM. SHE WAS TAKEN BY AMBULANCE TO THE ER, WHERE SHE RECEIVED A CT SCAN, WAS GIVEN PAIN KILLERS AND SENT HOME THE SAME DAY. 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 15573403 ↗
• InjuryOct 10, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A POWER SCOOTER BY AN END USER'S DAUGHTER, WHO STATED "HER MOTHER WAS USING THE SCOOTER INSIDE THE HOME ON HARDWOOD FLOORS TO GET AROUND THE HOUSE AND THE SCOOTER FELL ON HER." SHE WAS REPORTEDLY TAKEN TO THE HOSPITAL AND DIAGNOSED WITH A BROKEN WRIST AND FRACTURED LEG, AND HAS BEEN IN A REHAB FACILITY SINCE THE INCIDENT. 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 15571527 ↗
• InjuryJul 11, 2022Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  DRIVE DEVILBISS WAS NOTIFIED OF AN INCIDENT INVOLVING A POWER CHAIR BY DISTRIBUTOR, WHO REPORTED RECEIVING A COMPLAINT FROM AN END USER THAT WHILE THE END USER SEATED ON THE UNIT AND REACHING TO PUT SOMETHING IN THE REFRIGERATOR, THE UNIT TIPPED OVER. SHE WAS TAKEN BY AMBULANCE TO THE HOSPITAL, BROKE HER HIP IN 3 PLACES AND HAD SURGERY. THE UNIT WAS RETURNED TO DRIVE FOR EVALUATION, WHERE IT WAS DETERMINED TO BE WORKING AS INTENDED, WITH NO APPARENT DEFECT. THE OWNER'S MANUAL SPECIFICALLY WARNS AS FOLLOWS: "DO NOT STRETCH YOUR BODY OUT ON THE SCOOTER. SUCH ACTION MAY CAUSE YOU TO LOSE YOUR BALANCE OR BE INJURED."

  Patient problems: Hip Fracture

  MAUDE report 14977976 ↗
• InjuryNov 17, 2021Unintended Movement; Unintended Movement

  (B)(6) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A SCOOTER. 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 DATA BECOMES AVAILABLE. THE USER NOTED THAT HER SCOOTER'S BACK END WAS "ROCKING". IN CONSULTATION WITH OUR TECH DEPARTMENT WE RECOMMENDED REPLACEMENT. BEFORE THE REPLACEMENT WAS EXECUTED THE USER RODE THE DEVICE, FELL OFF, HIT HER HEAD, AND RECEIVED MEDICAL ATTENTION AT THE HOSPITAL. THEY ARE REQUESTING A 4 WHEEL UNIT TO REPLACE THE 3-WHEELED DAMAGED DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Fall; Head Injury

  MAUDE report 12828955 ↗