DEVICE DISPLACEMENT OR DISLODGEMENT WILL OCCUR WHEN PATIENT MOVES THE DEVICE IN SOME MANNER CONTRARY TO INSTRUCTIONS AND COUNSELING GIVEN ON THE DAY OF PLACEMENT. THE INFORMATION AS TO HOW THE EVENT OCCURRED IS OFTEN UNAVAILABLE. NO MANUFACTURER INVESTIGATION WAS UNDERTAKEN SINCE THIS WAS A FORESEEN RISK IN DEVICE USAGE AND IS CLEARLY NOTED BOTH IN THE IFU AND THE TRAINING PROGRAM. WE HAVE ATTACHED A COPY OF THE IFU WITH THE RELEVANT TEXT HIGHLIGHTED.
D
Patient 1
DEVICE DISLODGEMENT, REASON UNKNOWN, LEADING TO EDEMA, PATIENT WAS REFERRED TO SURGICAL CIRCUMCISION.