FDA Adverse Event Death Summary report: N

EHOB WAFFLE OVERLAY MATTRESS

MDR report key: 19558215 · Received June 17, 2024

Report

Report Number
MW5156324
Event Type
Death
Date Received
June 17, 2024
Date of Event
April 18, 2024
Report Date
June 12, 2024
Manufacturer
EHOB, INC.
Product Code
IKY
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
ID, US
Reporter Occupation
NURSE
Health Professional
Yes

Narratives

Description of Event or Problem · 0

PATIENT HAD BEEN IDENTIFIED AS HIGH RISK FOR PRESSURE INJURY DUE TO COMPLEX MEDICAL HISTORY. TO PREVENT SKIN BREAKDOWN, AN EHOB WAFFLE MATTRESS WAS PLACED ON TOP OF THE HOSPITAL MATTRESS. DURING HER SLEEP, THE PATIENT ATTEMPTED TO REPOSITION HERSELF IN THE BED AND WAS ABLE TO ROLL OVER THE SIDE RAILS. SHE LANDED ON THE FLOOR ON HER RIGHT SIDE WHICH RESULTED IN AN IMPACTED NONDISPLACED SUBCAPITAL FRACTURE OF THE PROXIMAL RIGHT FEMUR. THE PATIENT WAS NOT A SURGICAL CANDIDATE AND WAS TRANSITIONED TO COMFORT CARE. SHE DIED ON (B)(6) 2024. CAUSE OF DEATH: SEVERE PROTEIN CALORIE MALNUTRITION SECONDARY TO DEMENTIA, COMPLICATED BY RIGHT FEMUR FRACTURE. A THOROUGH EVENT REVIEW WAS COMPLETED. IT WAS DETERMINED THAT THE HEIGHT OF THE WAFFLE MATTRESS CONTRIBUTED TO THE FALL. THERAPY DATES: (B)(6) 2024.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2315617 EHOB WAFFLE OVERLAY MATTRESS MATTRESS, FLOTATION THERAPY, NON-POWERED IKY EHOB, INC.

Patients

Seq Age Sex Outcome Treatment
1 93 YR Female Hospitalization| D| S