MAUDE Adverse Event Report: OSSUR MEXICO UNLOADER ONE; ORTHOSIS, LIMB BRACE

Catalog Number B-240529713

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

Patient wearing unloader one knee brace claims the product was causing pain on his affected side and he went to the emergency room for an infection.

Event Description

Patient wearing unloader one knee brace claims the product was causing pain on his affected side and he went to the emergency room for an infection.

• Brand Name: UNLOADER ONE
• Type of Device: ORTHOSIS, LIMB BRACE
• Manufacturer (Section D): OSSUR MEXICO; boulevard hector teran teran 2; edificio #1 col. canon del pad; tijuana, baja california 22680 ; MX 22680
• Manufacturer (Section G): OSSUR MEXICO; boulevard hector teran teran 2; edificio #1 col. canon del pad; tijuana, baja california 22680 ; MX 22680
• Manufacturer Contact: karen montes ; 27051 towne centre; foothill ranch, CA 92610 ; 9492757557
• MDR Report Key: 6900806
• MDR Text Key: 87636768
• Report Number: 3008523132-2017-00007
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/18/2017

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: Lay User/Patient
• Device Catalogue Number: B-240529713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/23/2017
• Initial Date FDA Received: 09/28/2017
• Supplement Dates Manufacturer Received: 08/23/2017
• Supplement Dates FDA Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: No
• 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