Drive 15001ABVRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00822383179490), received between Aug 28, 2019 and Aug 24, 2023 — classified as 4 injuries.

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

• InjuryAug 24, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF A COMPLAINT REGARDING A BED RAIL BY AN END USER'S HUSBAND, WHO STATED THAT SHE HAS "FALLEN OUT OF HER BED DUE TO THE RIGHT-SIDE RAIL NOT BEING UP." THE REPORTER STATED THAT KNOBS AND PINS OF THE RAIL WERE "JAMMED" OR BROKEN OFF. THE REPORTER DID NOT SPECIFY HOW THE RAIL CAME TO BE IN THAT CONDITION. THE END USER WENT TO THE HOSPITAL AND WAS DIAGNOSED WITH 3 CRACKED RIBS. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO INSPECT THE PRODUCT, AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Fall; Multiple Fractures

  MAUDE report 17613375 ↗
• InjuryJul 21, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF A COMPLAINT REGARDING A BED RAIL BY AN END USER'S AIDE, WHO STATED THAT SHE "FOUND [THE END USER] WITH HIS NECK AND ARM STUCK IN THE BED RAIL," AND THAT "THE SPRING-LOADED KNOB HAS FAILED AND THEY ARE NO LONGER ABLE TO ADJUST THE RAILS." THE AIDE DID NOT SPECIFY THE LOCATION WHERE THE END USER'S NECK AND ARM WERE STUCK. THE AIDE REPORTED THAT THE END USER SUSTAINED SOME BRUISING TO HIS KNEES, BUT DID NOT SPECIFY HOW THE BRUISING WAS RELATED TO THE INCIDENT. THE AIDE SPECIFIED THAT THE END USER DID NOT REQUIRE ANY MEDICAL TREATMENT. DRIVE MADE SEVERAL ATTEMPTS TO CONTACT THE REPORTER AND END USER IN ORDER TO RETRIEVE THE PRODUCT FOR INSPECTION BUT WAS UNABLE TO MAKE FURTHER CONTACT. DRIVE WILL CONTINUE TO MONITOR FOR ANY RELATED TRENDS.

  Patient problems: Bruise/Contusion

  MAUDE report 17371068 ↗
• InjuryFeb 12, 2021Sharp Edges; Sharp Edges

  (B)(6) HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A BED RAIL. WE HAVE NOT EVALUATED THE DEVICE AS THE SERVICE PROVIDER IS HOLDING IT AT THEIR FACILITY. WE WILL FILE A FOLLOW-UP REPORT ONCE WE ARE ABLE TO EVALUATE THE DEVICE AND/OR RECEIVE ADDITIONAL INFORMATION. END-USER REPORTED HE HAD TO GO TO THE HOSPITAL DUE TO A CUT AND INFECTION IN HIS RIGHT LEG. HE WAS NOT SURE HOW HE GOT THE CUT ON HIS LEG. AFTER BEING DISCHARGED FROM THE HOSPITAL HE FOUND A "SHARP SPOT" ON THE SIDE RAILS THAT CUT HIS HAND.

  Patient problems: Laceration(s)

  MAUDE report 11323258 ↗
• InjuryAug 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) IS THE INITIAL IMPORTER OF THE DEVICES: A BED RAIL AND A LOW "AIT" LOSS SYSTEM. PATIENT WAS IN HOSPICE CARE WHEN THE INCIDENT OCCURED. THE PATIENT 'S DAUGHTER REPORTED TO SERVICE TECHNICIAN DURING EQUIPMENT PICK THAT PATIENT GOT FOOT STUCK BETWEEN THE BED AND HEAD BOARD CAUSING HER TO LOSE BLOOD FLOW. SHE STATED SHE HAD A CHOICE TO AMPUTATE FOOT OR SUFFER FROM GANGRENE UNTIL SHE DIED. HOSPICE REPORTED TO THE PROVIDER THAT PATIENT HAD FOOT INJURY. THEY VISITED THAT DAY TO EVALUATE PATIENT FOOT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Bruise/Contusion

  MAUDE report 8942564 ↗