DRIVEMEDICAL 100FDLRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00822383294315), received between Apr 5, 2024 and Apr 5, 2024 — classified as 1 injury.

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. 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.

• InjuryApr 5, 2024Sharp Edges; Sharp Edges

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A FULL-FACE MASK FOR A CPAP OR BIPAP BY AN END USER, WHO REPORTED THAT "AT THE ENDS OF THE VELCRO STRAPS THERE IS A SHARP BLACK TAB THAT CUT INTO MY EYELID." THE END USER REPORTED THE MASK STRAPS CAUSED STYES, A BACTERIAL INFECTION, AN ABSCESS OF THE EYELID, AND A HOSPITAL STAY INCLUDING THREE DAYS OF IV ANTIBIOTICS. IT IS UNCLEAR WHETHER THE DEVICE HAS BEEN PRESERVED OR CAN BE RETURNED FOR EVALUATION. DRIVE DEVILBISS IS INVESTIGATING THE INCIDENT, AND AN UPDATE WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Abscess; Bacterial Infection; Eye Infections

  MAUDE report 19055817 ↗