Joerns DermaFloat LAL Mattress (REF DFLAL-4280-M)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00857268006103), received between Jan 8, 2025 and Apr 22, 2025 — classified as 1 injury, 2 malfunctions.

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

• InjuryApr 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO THE MANUFACTURER, BY THE END USER, PER THE END USER, THAT PER ATTORNEY (B)(6), PATIENT WAS HURT ON MATTRESS WHILE ADMITTED (B)(6) 2021 - (B)(6 )2022. JOERNS WAS NOTIFIED OF THIS INCIDENT ON (B)(6) 2025. COMPLAINT # (B)(4) WAS ENTERED INTO OUR SYSTEM.

  Patient problems: Insufficient Information

  MAUDE report 21885708 ↗
• MalfunctionFeb 6, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED TO THE MANUFACTURER, BY THE END USER, PER THE END USER, THAT PER WIFE, PT FELL OFF THE SLIPPERY, HARD DFLAL MATTRESS AND WAS NOT HURT OR NEED MEDICAL ATTENTION BUT ONLY REQUESTED FOR THE DFLAL TO BE PICKED UP. PU ORDER (B)(4). MATTRESS SN: (B)(6). CU SN: (B)(6). COMPLAINT # (B)(4) AND RA # 84096656 WERE ENTERED INTO OUR SYSTEM TO HAVE THE PRODUCTS RETURNED FOR INVESTIGATION. AS OF THIS WRITING, THE PRODUCTS HAVE NOT BEEN RETURNED.

  Patient problems: Fall

  MAUDE report 21329714 ↗
• MalfunctionJan 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO THE MANUFACTURER, BY THE END USER, PER THE END USER, THAT WHEN CAREGIVER SAIDS SHE FOUND THE PT (MOM) ON THE FLOOR, NOT SURE HOW OR WHEN SHE FELL OUT OF THE BED. - THEY HAVE A MATTRESS ON THE FLOOR NEXT TO THE BED AND SHE FELL ONTO THAT MATTRESS - - HER MOM CAUGHT HER ARM IN THE BED RAIL, AND CAREGIVER NEEDED TO CALL 911 FOR HELP GETTING HER UP AND BACK INTO BED - NO INJURIES, NOT TAKEN TO HOSPITAL (B)(6) (CU400-69065); MATTRESS (B)(6) (NO S/N DATA AVAIL) SNS DO NOT PULL ANY ORDER DATA UP. COMPLAINT # (B)(4). WAS ENTERED INTO OUR SYSTEM.

  Patient problems: Fall

  MAUDE report 21107422 ↗