DRIVEMEDICAL K318ADDA-SFRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00822383133171), received between May 22, 2020 and Nov 8, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Sharp Edges” (2 reports).

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

• InjuryNov 8, 2023Mechanical Problem; Mechanical Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A CRUISER THAT THE WHEEL DID NOT TURN WELL. THE END USER REPORTED TO HAVE A BUSTED LIP THAT REQUIRED 5 STITCHES. IT IS UNKNOWN WHAT CAUSED THE INCIDENT. AN UPDATE WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Laceration(s)

  MAUDE report 18095594 ↗
• MalfunctionOct 27, 2023Sharp Edges; Sharp Edges

  WE RECEIVED THE EMAIL FROM OUR CUSTOMER DRIVE, THE DETAILS AS BELOW: DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A WHEELCHAIR. END-USER WAS SITTING IN A LIFT RECLINING CHAIR WITH A WHEELCHAIR WAS IN FRONT OF HER. SHE PUT HER FOOT FORWARD AND IT HIT A SHARP EDGE OF THE WHEEL ON THE WHEELCHAIR. SHE CUT TWO OF HER TOES AND STARTED TO BLEED A LOT BECAUSE SHE IS ON BLOOD THINNERS. THE MEDICAL DEVICE INVOLVED IN THE INCIDENT IS A WHEELCHAIR, ITEM # K318ADDA-SF. THE SERIAL NUMBER IS (B)(6).

  Patient problems: Laceration(s)

  MAUDE report 18026558 ↗
• InjuryMay 22, 2020Sharp Edges; Sharp Edges

  DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A WHEELCHAIR. END-USER WAS SITTING IN A LIFT RECLINING CHAIR WITH A WHEELCHAIR WAS IN FRONT OF HER. SHE PUT HER FOOT FORWARD AND IT HIT A SHARP EDGE OF THE WHEEL ON THE WHEELCHAIR. SHE CUT TWO OF HER TOES AND STARTED TO BLEED A LOT BECAUSE SHE IS ON BLOOD THINNERS.

  Patient problems: Laceration(s)

  MAUDE report 10084351 ↗