MAUDE Adverse Event Report: OSSUR AMERICAS SHOE DH OFFLOAD MD; SHOE CAST

Model Number 10341

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pressure Sores (2326)

Event Date 11/09/2016

Event Type  Injury  

Event Description

Fda medwatch report received indicating: the top cap seam caused abrasive pressure resulting in a blister.The patient visited the doctor and medications were provided to treat the ulcer but eventual amputation of the 5th metatarsal and 5th toe was needed.There was no indication of the original fitting fo the dh offloading shoe.

Event Description

Fda medwatch report received indicating: the top cap seam caused abrasive pressure resulting in a blister.The patient visited the doctor and medications were provided to treat the ulcer but eventual amputation of the 5th metatarsal and 5th toe was needed.There was no indication of the original fitting fo the dh offloading shoe.

• Brand Name: SHOE DH OFFLOAD MD
• Type of Device: SHOE CAST
• Manufacturer (Section D): OSSUR AMERICAS; 27051 towne centre; foothill ranch CA 92610
• Manufacturer (Section G): OSSUR AMERICAS; 27051 towne centre; foothill ranch CA 92610
• Manufacturer Contact: karen montes ; 27051 towne centre drive; foothill ranch, CA 92610 ; 9492757557
• MDR Report Key: 6245849
• MDR Text Key: 64654244
• Report Number: 2085446-2017-00001
• Device Sequence Number: 1
• Product Code: IPG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 03/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 10341
• Device Catalogue Number: 10341
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention