MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; PROTECTOR,HEEL,HEELMEDIX W/WEDGE,4/CS

Catalog Number MDT823330SWCS

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

Patient Problem Pressure Sores (2326)

Event Date 08/01/2021

Event Type  Injury  

Manufacturer Narrative

It was reported that a patient experienced a pressure ulcer during use of the product.Reportedly, the heel protector was used in conjunction with an sequential compression device (scd) sleeve.The pressure ulcer was noted by the reporting facility's wocn nurse who indicated that it "was not a sizing issue, it was tubing from the scd." no information was provided as to what stage the pressure ulcer was at the time that it was noted and no information related to medical treatment was provided to the manufacturer.No sample was available to be returned for evaluation and a root cause could not be determined at this time.Due to the reported development of a pressure ulcer, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that a patient experienced a pressure ulcer during use of the product.

• Type of Device: PROTECTOR,HEEL,HEELMEDIX W/WEDGE,4/CS
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 12352104
• MDR Text Key: 267623505
• Report Number: 1417592-2021-00160
• 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: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MDT823330SWCS
• Initial Date Manufacturer Received: 08/01/2021
• Initial Date FDA Received: 08/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other