Jada Warnings

Do not use Jada or other components if damage is apparent or there is doubt as to whether the device or components are sterile. Use of non-sterile device or components may lead to increased risk of infection.
Avoid excessive force when inserting the Jada into the uterus or trauma to uterine wall may occur, including perforation.
The use of Jada is not a substitute for appropriate medical management of Disseminated Intravascular Coagulation (DIC). The safety and effectiveness of the use of Jada in patients with DIC have not been evaluated.
The safety and effectiveness of the Jada System in delivery at a gestational age under 34 weeks or, if multiples, uterus judged under 34 weeks size, have not been established. With smaller uterine size, there is potential for increased risk of perforation and expulsion.
The safety and effectiveness of the Jada System after 24 hours following delivery have not been evaluated.
Signs of patient deterioration or failure to improve indicate the need for reassessment and possibly more aggressive treatment and management of postpartum hemorrhage (PPH) or abnormal postpartum uterine bleeding.
Jada is not a substitute for surgical and medical management and fluid resuscitation of life-threatening PPH/abnormal postpartum uterine bleeding.
Remove air from the Cervical Seal prior to device use to minimize risk of air embolism if the 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.
Jada and other components are for single patient use only. Do not reuse, reprocess, or re-sterilize. Reuse of Jada and other components may lead to cross contamination, infection, or patient death.