MAUDE Adverse Event Report: ALYDIA HEALTH JADA SYSTEM; INTRAUTERINE VACUUM CONTRACTION SYSTEM

Model Number JADA - 1001

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/16/2022

Event Type  Injury  

Event Description

In response to the question on the jes about "how quickly did the jada system control the abnormal postpartum uterine bleeding due to uterine atony?" the health care provider (hcp) indicated the check box that marked, "jada did not stop the abnormal postpartum uterine bleeding" and under the section "jada did not work" on the jes the hcp wrote in, "was not able to get pass internal os- clamped down 1 cm - used ring forcep." the patient in this event is described as multiparous, she delivered via emergency caesarean section (c-section) and her pph started 1-6 hours after delivery.Prior to jada treatment she was given hemabate (1 unit), cytotec (800 mcg), methergine (unknown dose, illegible), and txa (unknown dose, illegible) and ebl was 850 ml.The hcp reported placing 120 ml of sterile fluid in the cervical seal, but they were unable to get past the internal os as the patient was only cm dilated.There is no other information regarding this event on this jes.On 02/04/2022 the hcp responded with additional information via email.This patient was described as a (b)(6) female.They discarded the jada that they attempted to place on (b)(6) 2022, and no lot number was documented for this case.They administered cytotec 800 mcg rectally after attempting to place jada, no further bleeding was noted.No other information was provided for this case.

Manufacturer Narrative

Per the jada system instructions for use "secure visualization of the cervix to confirm it is dilated greater than 3 cm to allow for placement of jada." based on the overall information currently available in this report, there is no clear evidence that the jada system caused or contributed to the need for any escalating treatment to preclude permanent body damage/impairment.Although it was reported that jada did not stop the abnormal post-partum bleeding, the lack of adequate cervical dilation (reported as 1 cm) precluded the jada system to pass through the internal cervical os and be positioned appropriately in the uterus to control the abnormal post-partum bleeding.However, out of an abundance of caution, the company will report this case as a serious injury mdr.

Event Description

In response to the question on the jes about "how quickly did the jada system control the abnormal postpartum uterine bleeding due to uterine atony?" the health care provider (hcp) indicated the check box that marked, "jada did not stop the abnormal postpartum uterine bleeding" and under the section "jada did not work" on the jes the hcp wrote in, "was not able to get pass internal os- clamped down 1 cm - used ring forcep." the patient in this event is described as multiparous, she delivered via emergency caesarean section (c-section) and her pph started 1-6 hours after delivery.Prior to jada treatment she was given hemabate (1 unit), cytotec (800 mcg), methergine (unknown dose, illegible), and txa (unknown dose, illegible) and ebl was 850 ml.The hcp reported placing 120 ml of sterile fluid in the cervical seal, but they were unable to get past the internal os as the patient was only cm dilated.There is no other information regarding this event on this jes.On 02/04/2022 the hcp responded with additional information via email.This patient was described as a (b)(6) female.They discarded the jada that they attempted to place on (b)(6) 2022, and no lot number was documented for this case.They administered cytotec 800 mcg rectally after attempting to place jada, no further bleeding was noted.No other information was provided for this case.

Manufacturer Narrative

Per the jada system instructions for use "secure visualization of the cervix to confirm it is dilated greater than 3 cm to allow for placement of jada." based on the overall information currently available in this report, there is no clear evidence that the jada system caused or contributed to the need for any escalating treatment to preclude permanent body damage/impairment.Although it was reported that jada did not stop the abnormal post-partum bleeding, the lack of adequate cervical dilation (reported as 1 cm) precluded the jada system to pass through the internal cervical os and be positioned appropriately in the uterus to control the abnormal post-partum bleeding.However, out of an abundance of caution, the company will report this case as a serious injury mdr.

• Brand Name: JADA SYSTEM
• Type of Device: INTRAUTERINE VACUUM CONTRACTION SYSTEM
• Manufacturer (Section D): ALYDIA HEALTH; 3495 edison way; menlo park CA 94025
• Manufacturer (Section G): ALYDIA HEALTH; 3495 edison way; menlo park CA 94025
• Manufacturer Contact: heather wisler ; 3495 edison way; menlo park, CA 94025 ; 8445232666
• MDR Report Key: 13552679
• MDR Text Key: 286020719
• Report Number: 3017425145-2022-00010
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 00850017882003
• UDI-Public: (01)00850017882003
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: JADA - 1001
• Device Catalogue Number: JADA-1001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Sex: Female