Drive 12005KD-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00822383225555), received between Feb 18, 2021 and Feb 16, 2023 — classified as 3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 16, 2023Break; Break

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A BATH TRANSFER BENCH BY AN ATTORNEY, WHO STATED THAT "THE END USER SAT ON THE SHOWER CHAIR AND THE BACK REST BROKE OFF, CAUSING HIM TO FALL BACKWARDS AND LAND DIRECTLY ON HIS HEAD." THE END USER WENT TO THE ER, WHERE HE WAS REPORTEDLY DIAGNOSED WITH A CONCUSSION. 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: Head Injury

  MAUDE report 16388829 ↗
• InjuryMay 3, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A BATH SAFETY DEVICE. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. WE ARE FILING THIS REPORT IN AN OVERABUNDANCE OF CAUTION. A FOLLOW-UP REPORT WILL BE FILED WHEN WE RECEIVE NEW INFORMATION. THE END-USER WAS IN REHAB AND WAS ADMINISTERED MIND-ALTERING PAIN KILLER MEDICATION. HE WAS PLACED ON A BATH BENCH. AFTER HE WAS SOAPED, THEY INSTRUCTED HIM TO SLIDE FORWARD AND THEN ATTEMPTED TO LIFT HIM FROM THE CHAIR. AT SOME POINT WHILE ON THE CHAIR, HIS LEFT TESTICLE BECAME CAUGHT IN AN OPENING IN THE CHAIR. HE WAS LIFTED FROM BY HIS LEFT TESTICLE REPORTEDLY CAUSING SEVERE AND PERMANENT INJURY TO HIM, INCLUDING TO HIS SCROTUM, TESTIS AND MALE GENITALIA.

  Patient problems: Laceration(s)

  MAUDE report 11766906 ↗
• InjuryFeb 18, 2021Fracture; Fracture

  DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A BATH BENCH. WE ARE FILING THIS REPORT IN AN OVER ABUNDANCE OF CAUTION AND TO BE TIMELY. WE WILL SUBMIT A FOLLOW-UP REPORT WHEN NEW DATA BECOMES AVAILABLE. WHILE IN USE THE CHAIR BACK REPORTED;Y BROKE. THE END-USER FELL BACKWARDS AND HIT HIS HEAD IN THE SHOWER. THE ED-USER IS UNWILLING TO SHARE ADDITIONAL PERSONAL INFORMATION.

  Patient problems: Fall; Head Injury

  MAUDE report 11345521 ↗