Joerns DermaFloat LAL Mattress (REF DFLAL-3680-M)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00857268006097), received between Aug 17, 2025 and Sep 12, 2025 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathSep 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO THE MANUFACTURER, BY THE END USER, PER THE END USER, THAT PER ETC - ARRIVED TO PICK-UP DFLAL FROM PATIENT'S HOME, DURING THE COURSE OF THE PICK-UP THE PATIENT DAUGHTER, THAT HER MOTHER HAD BEEN CONFUSED OVER THE LAST FEW DAYS AND SHE HAD FOUND HER FACE DOWN ON THE FLOOR UNRESPONSIVE BY THE BED, SHE WAS LATER PRONOUNCED DEAD. DOES NOT SEEM AS IF OUR PRODUCT IS AT FAULT BUT WILL INVESTIGATE PER PROCESS AND RETAIN ON SITE. COMPLAINT # (B)(4) AND RA # (B)(4) WERE ENTERED INTO OUR SYSTEM TO HAVE THE UNITS RETURNED FOR INVESTIGATION. AS OF THIS WRITING, THEY HAVE NOT BEEN RETURNED.

  Patient problems: Insufficient Information

  MAUDE report 23045744 ↗
• MalfunctionAug 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO THE MANUFACTURER, BY THE END USER, PER THE END USER, THAT PER RN, THE PATIENT FELL OUT OF BED ON (B)(6) 2025 IN THE AFTERNOON. NO KNOWN WITNESSES, SHE WASN'T THERE. THE PATIENT WAS SENT TO HOSPITAL AFTER THE FALL AND STAYED OVERNIGHT, NO REPORTED INJURIES. COMPLAINT # (B)(4) WAS ENTERED INTO OUR SYSTEM.

  Patient problems: Fall

  MAUDE report 22824543 ↗