MERITS P326AEARMUBRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04714379292541), received between Apr 8, 2021 and Apr 8, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

1 other recall cover devices cleared under the same FDA submission (K012802); they may or may not involve this specific model.

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 16, 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.

• MalfunctionApr 8, 2021Fracture; Fracture

  PATIENT WAS AT HER NEIGHBOR'S HOUSE AND AS SHE LEFT HER DRIVEWAY THAT HAD SLIGHT INCLINE THE SEAT POST OF THE CHAIR SHEARED OFF CAUSING HER TO FALL OUT OF THE CHAIR WITH THE SEAT ON TOP OF HER CAUSING INJURY. SHE DID NOT WANT TO GO TO THE HOSPITAL DUE TO COVID. NO AMBULANCE WAS CALLED, HER NEIGHBOR JUST BROUGHT HER INTO THE HOUSE. SHE HAVE A DR'S APPOINTMENT (B)(6) 8:00 AM.

  Patient problems: Fall

  MAUDE report 11637771 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K012802. One submission often covers many models, so check the product and lot details in each record.

• Z-1504-2021 · Apr 1, 2021 · Open, Classified
  Power Wheelchair