inforMED
MalfunctionFMP

FOOT WAFFLE HEEL PROTECTOR

Received Nov 16, 2022 · Event occurred Oct 5, 2022

Report 15804226 · MDR key 15804226

Device

Generic name

Protector, Skin Pressure

Manufacturer

Ehob, Inc.

Model number

EHO345CX

Lot number

UNKNOWN

Product problems

  • Deflation Problem

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

RN GOT A BRAND-NEW WAFFLE HEEL PROTECTOR FOR A PATIENT AND BOTH THE SIDES WERE DEFLATED. ITEM IS LOCATED IN ROOM 5615 WITH THE ASSISTANT PATIENT SERVICE MANAGER. MANUFACTURER RESPONSE FOR WAFFLE HEEL PROTECTOR, WAFFLE HEEL PROTECTOR (PER SITE REPORTER) ADDED TO TRACKER FOR TRENDING, 10/25 RETRIEVING. EHOB REG, MANUFACTURER WILL SEND IN A REPLACEMENT PRODUCT DIRECT. MATT WILL WORK TO RETRIEVE THE DEFECTIVE SAMPLE.