The JADA® System FAQs

FAQ

Frequently Asked Questions

See below for answers to frequently asked questions about the JADA^® System.

FAQs

How long does it take to control bleeding?

94% (n=100) of subjects in the PEARLE Study had bleeding controlled in less than 10 minutes.

How do I know JADA is working? How do I know when to discontinue treatment?

Leave JADA in place with vacuum applied until bleeding is controlled for 1 hour and continue to assess if the patient’s uterus is firm, bleeding is controlled, and the patient is stable. Leave JADA in place with vacuum disconnected and fluid removed from the Cervical Seal for a minimum of 30 minutes and continue to check that the bleeding remains controlled, and the uterus remains firm.

Can JADA be used in C-section patients?

Yes. Ensure the cervix is dilated to at least 3 cm before use of JADA and verify that the hysterotomy is closed prior to insertion. JADA should be placed transvaginally; do not place through the incision.

Can I transfer a patient who is on active vacuum suction with JADA in place?

Leave JADA in place with regulated vacuum applied until bleeding is controlled for at least 1 hour, the uterus is firm, and the patient is stable. If patient transfer is necessary, it is up to the healthcare professional’s discretion and clinical judgment.

Can I use a portable vacuum suction device with JADA?

A portable vacuum can be used as long as it is a regulated vacuum source. It can be set to “continuous” suction, and it can be set to 80 mm Hg (+/- 10 mm Hg).

Can lubrication be used when placing JADA?

There is no current restriction around using lubrication with the JADA System.

Can JADA be used in patients with chorioamnionitis?

Yes, if there is no purulent infection.

How much blood can fit in the tubing?

The tubing that is supplied with the JADA System can hold around 100 mL of blood/fluid.

Can the JADA be reinserted if it slides out of place?

JADA is indicated for single-patient use. Reinsertion is up to the healthcare professional’s discretion and clinical judgment.

Should antibiotics be used with JADA?

Consider prophylactic antibiotics for prolonged use.

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Indications, Contraindications, and Warnings

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.

Contraindications

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

FAQ