MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. HEEL MEDIX BASIC HEEL PROTECTOR; PROTECTOR, SKIN PRESSURE

Model Number MDT 6300CS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pressure Sores (2326)

Event Date 04/13/2020

Event Type  malfunction  

Event Description

Observed that patient was developing a pressure injury to the right lateral and medial aspect of foot secondary to new off loading boots, medline heel medix.It is off loading however, for people with fragile skin it causes pressure injury.The wound care nurse has seen this occur in other patients at other hospitals.Therapy dates: (b)(6) 2020.Fda safety report id# (b)(4).

• Brand Name: HEEL MEDIX BASIC HEEL PROTECTOR
• Type of Device: PROTECTOR, SKIN PRESSURE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.
• MDR Report Key: 10013234
• MDR Text Key: 189618707
• Report Number: MW5094321
• Device Sequence Number: 1
• Product Code: FMP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MDT 6300CS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/29/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 82 YR