DONJOY

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE PATIENT SUSTAINED AND INTERNAL INJURY THAT REQUIRED MEDICAL ATTENTION DUE TO WEARING THE BRACE. THE PATIENT NOW HAS A KNEE STRAIN AND CANNOT RUN OR CROSS THEIR LEGS COMFORTABLY. THE PATIENT MUST ICE HER KNEE TO RELIEVE THE PAIN. THE PATIENT STATED NO PAIN WAS FELT WHILE RUNNING BUT NOW IT IS INTENSE AND HAS LASTED FOR DAYS, THE ONLY CHANGE IS THE KNEE BRACE. THE PATIENT REQUESTED THE OLDER VERSION OF THE BRACE. A REPLACEMENT BRACE WAS PROVIDED TO THE PATIENT. THE BRACE WAS NOT RETURNED FOR EVALUATION; PHOTOS OF THE INJURY WERE ALSO NOT PROVIDED. THE INJURY IS INTERNAL PAIN THAT WILL REQUIRE IMAGING. IF ADDITIONAL INFORMATION ON THIS REPORTED EVENT BECOMES AVAILABLE THIS INVESTIGATION WILL BE REEVALUATED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT SUSTAINED AND INTERNAL INJURY THAT REQUIRED MEDICAL ATTENTION DUE TO WEARING THE BRACE.