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Drive 16500BVRecalls & reported problems

Drive Devilbiss Healthcare · Bed Rail, Home Style, Brown Vein, 1pr/cs · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00822383160498), received between Apr 15, 2019 and Apr 15, 2019 — classified as 1 injury.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Laceration(s)1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    (B)(6) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A BED RAIL. WE ARE AWAITING RETURN OF THE DEVICE FOR EVALUATION. IT IS NOT BELIEVED THAT THE DEVICE FAILED. THE END USER WAS TRYING TO LOWER THE RAILS FROM INSIDE THE BED AND THE RAILS GOT STUCK. WHILE REACHING OVER SHE GOT HER LEG CAUGHT IN THE RAIL. SHE CUT, RIGHT CALF. WHICH REQUIRED 29 STITCHES.

    Patient problems: Laceration(s)

    MAUDE report 8516221 ↗

Other BED, MANUAL devices

All BED, MANUAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.