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

Model Number UOX0518714

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

Patient Problem Unspecified Infection (1930)

Event Date 02/25/2020

Event Type  Injury  

Manufacturer Narrative

The user sustained an infected ingrown hair, which required medical intervention to drain and remove.It is difficult to confirm whether the brace caused this event as ingrown hairs may occur without the use of a brace.It is expected that the user will make a full recovery.The likelihood of this type of failure leading to a hazardous event resulting in a serious injury is considered remote.No further action is warranted at this time and we will continue to monitor the issue.

Event Description

The user sustained an infected ingrown hair which required medical intervention to drain and remove.

• Brand Name: UNLOADER ONE X
• 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: 9961358
• MDR Text Key: 187692217
• Report Number: 3008523132-2020-00001
• Device Sequence Number: 1
• Product Code: IQI
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,user facilit
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UOX0518714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR