IsoTour 2872 (REF 2872-000-012)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327424638), received between Apr 27, 2020 and Oct 4, 2024 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT THERE WAS AN INCREASE IN UNSPECIFIED PRESSURE INJURIES. SPECIFIC NUMBERS, SEVERITY OF INJURY, AND TREATMENT DETAILS HAVE NOT BEEN PROVIDED AT THE TIME OF REPORTING.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 20369659 ↗
• MalfunctionSep 6, 2024Adverse Event Without Identified Device or Use Problem; Material Too Soft/Flexible; Adverse Event Without Identified Device or Use Problem; Material Too Soft/Flexible

  IT WAS REPORTED THAT THE GEL SECTIONS ON THE DEVICE ARE SEPARATING. IT WAS FURTHER REPORTED THAT THE PATIENT HAS A WORSENING PRESSURE INJURY.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 20161596 ↗
• MalfunctionMar 29, 2024Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT A STAFF MEMBER WAS INJURED DUE TO THE WEIGHT OF THE ISOTOUR MATTRESS DURING CLEANING. IT WAS FURTHER REPORTED THAT A USER RECEIVED FIRST AID.

  Patient problems: Insufficient Information

  MAUDE report 19007612 ↗
• MalfunctionMar 29, 2024Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT THERE WAS NEAR MISS INJURY WITH A USER DUE TO THE WEIGHT OF THE ISOTOUR MATTRESS DURING CLEANING, BUT NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19007602 ↗
• MalfunctionNov 28, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT A STAFF MEMBER WAS INJURED DUE TO THE WEIGHT OF THE ISOTOUR MATTRESS DURING CLEANING. ATTEMPTS ARE BEING MADE TO GATHER ADDITIONAL INJURY AND TREATMENT DETAILS FROM THE USER FACILITY.

  Patient problems: Insufficient Information

  MAUDE report 18222451 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, WHILE USING THE SURFACE, THE PATIENT COMPLAINED OF PAIN IN THEIR SACRAL AREA. IT WAS DISCOVERED THAT THE SURFACES GEL HAD SEPARATED, AND THE PATIENT WAS SITTING ON THE FRAME OF THE MATTRESS. THE PATIENT SUSTAINED A NEW STAGE 2 PRESSURE INJURY.

  Patient problems: Pain; Pressure Sore/Ulcer

  MAUDE report 18183431 ↗
• MalfunctionApr 26, 2022Difficult or Delayed Positioning; Difficult or Delayed Positioning

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED MATTRESS HEAVY/HARD TO MOVE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14209264 ↗
• MalfunctionJul 27, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE WAS TOO HEAVY/DIFFICULT TO MOVE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12234214 ↗
• MalfunctionApr 27, 2020Device-Device Incompatibility; Device-Device Incompatibility

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT, WHERE IT WAS REPORTED IT WAS DIFFICULT TO ENTER AN XRAY CASSETTE WITH THE DEVICE.  THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10001506 ↗