Bakri Postpartum Balloon: Procedural steps and animation

ESSENTIAL PRESCRIBING INFORMATION

INDICATIONS: Intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted. CONTRAINDICATIONS: Arterial bleeding requiring surgical exploration or angiographic embolization ˆ Cases indicating hysterectomy ˆ Pregnancy ˆ Cervical cancer ˆ Purulent infections in the vagina, cervix, or uterus ˆ Untreated uterine anomaly ˆ Disseminated intravascular coagulation ˆ Surgical site that would prohibit device from effective controlling bleeding. WARNINGS: Device should not be left indwelling for more than 24 hours ˆ Do not exceed maximum inflation volume of 500 ml ˆ Clinical data supporting the safety and effectiveness of this device in the setting of uterine atony are limited; patients should be closely monitored for signs of worsening bleeding and/or disseminated intravascular coagulation. In such cases, emergency intervention should be performed per hospital protocol ˆ No clinical data exist to support the use of this device in the setting of DIC ˆ Signs of deteriorating or non-improving condition should lead to more aggressive treatment and management of patient uterine bleeding. PRECAUTIONS: Avoid excessive force when inserting balloon into uterus.

INSTRUCTIONS FOR USE (IFU):
https://ifu.cookmedical.com/ifuPub/downloadifu.jsf?fileName=U_J-SOS_REV1.PDF

FOR MORE INFORMATION:
http://www.cookmedical.com/wh/dataSheet.do?id=4487

Category:

Science & Technology

Tags:

• Postpartum hemorrhage
• maternal mortality
• Bakri Postpartum Balloon
• tamponade
• PPH