MAUDE Adverse Event Report: OSSUR AMERICAS FOOT UP; ORTHOSIS

Model Number 27810-2

Device Problem Insufficient Information (3190)

Patient Problems Pressure Sores (2326); No Code Available (3191)

Event Date 11/23/2015

Event Type  Injury  

Manufacturer Narrative

Aktiv ortopedteknick stated they are uncertain that this claim of injury is related to the product since the damage was on the toe and the product is used on the ankle.We are working to obtain further information from the clinic and patient.

Event Description

Very little information was provided by the customer.We are working with them to obtain more information.The claim is the patient had a toe amputated due to pressure sores.

Manufacturer Narrative

(b)(4) stated they are uncertain that this claim of injury is related to the product since the damage was on the toe and the product is used on the ankle.We are working to obtain further information from the clinic and patient.

Event Description

Very little information was provided by the customer.We are working with them to obtain more information.The claim is the patient had a toe amputated due to pressure sores.

• Brand Name: FOOT UP
• Type of Device: ORTHOSIS
• 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 ; 9493823741
• MDR Report Key: 5348122
• MDR Text Key: 35187748
• Report Number: 2085446-2016-00001
• Device Sequence Number: 1
• Product Code: KNP
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 27810-2
• Device Catalogue Number: 27810-2
• Device Lot Number: EN090706
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/18/2015
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 73 YR