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

Catalog Number MDT823296

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

Patient Problem Injury (2348)

Event Date 09/01/2019

Event Type  Injury  

Manufacturer Narrative

It was reported that the end-user was discharged home with two (2) heel sores and the heel protectors were purchase for home use.Reportedly, after several days of use the end-user's family member identified "additional sores at the outside joint of the big toe on both feet and several small sores along the outside of booth feet." it was also noted that "the original two sores on the heels looked improved." the end-user's family member reported that the end-user experiences "twitching and nervously shaking" of his feet.The end-user is receiving follow-up at-home nursing care and the family member was provided with 3m cavilon no sting barrier film for use on the sores.Use of the heel protectors were discontinued and the family member is, instead, using pillows under the end-user's ankles and calves.A sample was returned to the manufacturer for evaluation.The heel protectors were found to have all seams intact with all components present and within specification.Both heel protectors were found to be able to offload pressure on the heel and fix the foot in place.Although a definitive root cause was unable to be determined, it is possible for the heel protectors to apply friction to the sides of the foot depending on an end-user's foot size.Due to the reported need for follow-up care and the additional sores, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that the end-user experienced additional sores to his feet.

• Type of Device: PROTECTOR, HEEL, HEEL RAISER, OSFM
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 9196730
• MDR Text Key: 162644693
• Report Number: 1417592-2019-00167
• Device Sequence Number: 1
• Product Code: ITW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDT823296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Date Manufacturer Received: 09/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention