inforMED
InjuryIKY

UNKNOWN

Received Apr 27, 2026 · Event occurred Mar 31, 2026

Report 1417592-2026-00608 · MDR key 25002319

Device

Generic name

Div30 Dme - Miscellaneous

Catalog number

DIV30

Product problems

  • Material Deformation

Patient

55 YR · Female

  • Pressure Sore/Ulcer

Narrative

Additional Manufacturer Narrative

ACCORDING TO THE CUSTOMER, "THE MATTRESS IS BECOMING FLAT" AND THAT THE USER "IS GETTING BED SORES BECAUSE OF THE MATTRESS BEING FLAT." PER THE CUSTOMER, THE USER IS "BEDBOUND" BUT "GETS ROTATED EVERY TWO HOURS." NO ADDITIONAL DETAILS ARE AVAILABLE RELATED TO THE CUSTOMER REPORTED ISSUE. DESPITE MULTIPLE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER CONTACT WAS UNABLE OR UNWILLING TO PROVIDE FURTHER INCIDENT DETAILS TO THE MANUFACTURER. NO ADDITIONAL INFORMATION IS AVAILABLE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Description of Event or Problem

ACCORDING TO THE CUSTOMER, "THE MATTRESS IS BECOMING FLAT" AND THAT THE USER "IS GETTING BED SORES BECAUSE OF THE MATTRESS BEING FLAT." PER THE CUSTOMER, THE USER IS "BEDBOUND" BUT "GETS ROTATED EVERY TWO HOURS."