Indications for Use

The JADA System is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted.

Important Safety Information

In the pivotal clinical study, there were no adverse events judged definitely related to the device or the procedure and there was a low rate of possibly related adverse events, all of which were anticipated in this patient population and with introduction of an intrauterine device. Five possibly device-related adverse events were rated as “mild” and three were rated as “moderate” without any event in this group rated “severe.” The 3 moderate events were cases of endometritis, which is a known risk of long labor, vaginal exam, and postpartum hemorrhage.

Before using JADA, please read the contraindications, warnings, precautions, and other important information in the accompanying Instructions for Use.

Patents

9,125,686 10,064,651
Additional patents may be pending.