DRIVEMEDICAL 6500-DE-2-FBRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00822383516431), received between Jul 14, 2022 and Jul 14, 2022.

The most frequently reported specific device problem is “Pressure Problem” (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 18, 2026.

Most reported problems

Recent adverse event reports

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

• No answer providedJul 14, 2022Pressure Problem; Pressure Problem

  DRIVE DEVILBISS HEALTHCARE WAS CONTACTED REGARDING A REPORTED INJURY INVOLVING A PRESSURE REDISTRIBUTION FOAM MATTRESS, WHICH IS INTENDED TO BE USED AS ONE COMPONENT OF A COMPREHENSIVE, MULTI-DISCIPLINARY PRESSURE INJURY MANAGEMENT PROGRAM. THE END USER, WHO IS BEDRIDDEN, REPORTED HAVING DEVELOPED BED SORES AFTER 8 MONTHS OF USE, REPORTEDLY DUE TO THE MATTRESS BECOMING VERY HOT. DRIVE DID NOT RECEIVE ANY INFORMATION REGARDING THE PATIENT'S OVERALL PRESSURE INJURY MANAGEMENT PROGRAM. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT TO EVALUATE IT. DRIVE WILL UPDATE THIS FILING IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Ulcer

  MAUDE report 15015277 ↗