Fast Control of Abnormal Postpartum Uterine Bleeding^1,*

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

• Ongoing intrauterine pregnancy
• Untreated uterine rupture
• Unresolved uterine inversion
• Current cervical cancer
• Known uterine anomaly
• Current purulent infection of vagina, cervix, or uterus
• For C-sections: Cervix <3 cm dilated before use of JADA

Warnings

• Avoid excessive force when inserting JADA into the uterus or trauma to uterine wall may occur, including perforation.
• The safety and effectiveness of the JADA System in delivery at a gestational age <34 weeks or, if multiples, uterus judged <34 weeks size, have not been established. With smaller uterine size, there is potential for increased risk of perforation and expulsion.
• Signs of patient deterioration or failure to improve indicate the need for reassessment and possibly more aggressive treatment and management of postpartum hemorrhage (PPH)/abnormal postpartum uterine bleeding.
• JADA is not a substitute for surgical management and fluid resuscitation of life-threatening PPH/abnormal postpartum uterine bleeding.
• Remove air from Cervical Seal prior to device use to minimize risk of air embolism if Cervical Seal bursts.
• Always fill the Cervical Seal with sterile fluid. Never inflate with air, carbon dioxide, or any other gas to minimize risk of air embolism if Cervical Seal bursts.

To report an adverse event or product quality complaint for JADA, please call 844-JADAMOM.

For general inquiries or to connect with a JADA Rep: jadainfo@organon.com

For existing customer support: USDirectCS@organon.com