MEDLINE
Received Jun 17, 2026 · Event occurred May 6, 2026
Report 1417592-2026-02596 · MDR key 25535751
Device
Generic name
Mattress, Foam,premium, 80"x36"x6"
Manufacturer
Medline Industries, LpCatalog number
MDR230981R
Product problems
- Material Deformation
Patient
80 YR · Male
- Pressure Sore/Ulcer
- Back pain
Narrative
Additional Manufacturer Narrative
ACCORDING TO THE CUSTOMER, THE "MATTRESS IS SINKING", AND IT CAUSED "BACK PAIN AND SORES". 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. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW-UP CARE. IT HAS BEEN DETERMINED THAT THE EVENT DID NOT INVOLVE A DEATH OR SERIOUS INJURY; HOWEVER, IT MEETS THE DEFINITION OF A REPORTABLE MALFUNCTION, AS RECURRENCE OF THE MALFUNCTION COULD CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. BASED ON THE INFORMATION REVIEWED, THIS IS A REPORTABLE EVENT AS DEFINED UNDER 21 CFR 803.3.
Description of Event or Problem
ACCORDING TO THE CUSTOMER, THE "MATTRESS IS SINKING", AND IT CAUSED "BACK PAIN AND SORES".