MAUDE Adverse Event Report: OSSUR MEXICO UNLOADER ONE; KNEE BRACE

Catalog Number B-240618713

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

Patient Problem Thrombosis/Thrombus (4440)

Event Date 05/20/2020

Event Type  Injury  

Event Description

The user received the product on (b)(6) 2019 and developed dvt in (b)(6) 2020.The doctor advised the user to use blood thinners if he wishes to wear the brace.

Manufacturer Narrative

It was reported that deep vein thrombosis (dvt) occurred while wearing the unloader one smart dosing brace.Medical intervention was required, however, there were no details on the intervention provided.It is difficult to determine root cause, as there are many factors that can contribute to dvt.Dvt is an inherent risk associated with general immobilization of a limb.However, the unloader is not intended to immobilize the leg or joint.The likelihood of this type of this type of injury (dvt) occurring after the use of this device is considered remote, furthermore a failure leading to a hazardous event resulting in a serious or catastrophic injury is considered remote.Issue is being monitored.No further action is warranted at this time.

Event Description

The user received the product on april 2019 and developed dvt in may 2020.The doctor advised the user to use blood thinners if he wishes to wear the brace.

• Brand Name: UNLOADER ONE
• Type of Device: KNEE BRACE
• Manufacturer (Section D): OSSUR MEXICO; blvd. hector teran teran 2102; build.#1 col. canon del padre; tijuana, baja california 22206 ; MX 22206
• Manufacturer Contact: katla axelsdottir ; grjothals 1-5; reykjavik, 110 ; IC 110
• MDR Report Key: 13192395
• MDR Text Key: 283476297
• Report Number: 3008523132-2022-00001
• Device Sequence Number: 1
• Product Code: ITQ
• Combination Product (y/n): N
• Reporter Country Code: NO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: B-240618713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR