MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. PROTECTOR, HEEL RAISER

Catalog Number MDT823200CS

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Ulcer (2274)

Event Date 08/20/2014

Event Type  Injury  

Event Description

It was reported that two pts developed a deep tissue injury to the heel 3-4 days after the heel raiser had been applied.

Manufacturer Narrative

The facility reported that after wearing the heel protectors for 3-4 days, two pts developed deep tissue injuries to their heels.Skin assessments were reported to have been done every four hours.Dressings were applied and off loading boots were initiated.Two heel protectors were returned, evaluated and found to be within specification.No issues, damage or product defects were found with the returned devices.A root cause has not been determined.We have no confirmed the devices caused the reported tissue injury.

• Brand Name: PROTECTOR, HEEL RAISER
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; mundelein IL 60060
• Manufacturer Contact: julie finley ; one medline place; mundelein, IL 60060 ; 8476434709
• MDR Report Key: 4176679
• MDR Text Key: 5019342
• Report Number: 1417592-2014-00088
• Device Sequence Number: 1
• Product Code: IQI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MDT823200CS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other