IMPORTANT SAFETY INFORMATION

Indication for Use

Dilapan-S^® is for use by healthcare professionals trained in OB/GYN whenever cervical softening and dilation are desired, such as for cervical ripening during term labor induction or gynecological procedures that require cervical preparation.

Contraindication

Dilapan-S^® is contraindicated in the presence of clinically apparent genital tract infection.

Warnings & Precautions

• Dilapan-S^® is intended for single use only. Do not reuse, resterilize, reprocess, or use if primary packaging has been opened or damaged. Discard after use.
• Careful placement of the device is essential to avoid traumatic injury to the cervix or uterus (see Instructions for Use—Insertion). The device should not be left in place more than 24 hours. Instruct patients to: Report any excessive bleeding, pain, or temperature elevation, and to avoid bathing, douching, and intercourse. Patients should return to the physician for removal of Dilapan-S^® at the indicated time and should be instructed not to attempt self-removal under any circumstances.
• Potential Complications/Risks: Twisting of device during removal may cause the device to break (see Instructions for Use—Removal). Complications may include: device entrapment and/or fragmentation, expulsion, or retraction; patient discomfort or bleeding; spontaneous rupture of membranes; spontaneous onset of labor; cervical laceration.

Storage & Handling: Store between +15°C and +30°C and keep away from direct sunlight and high humidity.

Please click here to download the Instructions for Use.

You are encouraged to report adverse events related to Dilapan-S^® by calling 1 (888) 257-9676. If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. Visit http://www.fda.gov/MedWatch or call 1-800-FDA-1088.