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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/07/2022

Event Type  Injury  

Manufacturer Narrative

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 escalating treatment (reported as bakri balloon) to preclude permanent body damage/impairment.Although it was reported that jada did not control the abnormal post-partum bleeding, the lack of adequate cervical dilation precluded the jada system to advance and be positioned appropriately in the uterus in order to control the abnormal post-partum bleeding.Per the jada system ifu "secure visualization of the cervix to confirm it is dilated greater than or equal to 3 cm to allow for placement of jada." and "for c-sections: it is contraindicted for cervix < 3 cm dilated before use of jada" however, out of an abundance of caution, the company will report this case as a serious injury mdr.".

Event Description

Alydia health received a jada experience survey (jes) on (b)(6) 2022, that had a handwritten statement in the area designated for 'what treatment(s) did you use to treat the abnormal postpartum uterine bleeding that was not controlled with the jada system?' that stated, "bakri balloon was inserted patient was not dilated enough and could not advance device into uterus." the patient in this case is described as having a history of prior postpartum hemorrhage, and asthmatic.She had a scheduled cesarean section (c-section) delivery and her abnormal postpartum uterine bleeding or pph started within one hour after delivery in the operating room (or).Prior to jada treatment she received unknown doses of cytotec, hemabate, methergine, and txa.The amount of blood loss prior to jada use was reported as "~800" ml.There is no report of if or how much sterile fluid the cervical seal was filled with.The amount of blood evacuated with the jada was not reported.This is consistent with the note that states the device was not able to be correctly placed due to inadequate cervical dilation.There is no other information for this case provided on this survey.There is limited information for this jes at this time.A request was sent to the site on 02/11/ 2022, to inquire if the lot number was available, if the device was retained, and follow up questions regarding this case.This site responded that they do not have a lot number for this case, and they did not retain the device.This site did not provide any additional information for this case.This case involves the attempted use of jada following a cesarean section where the patient's cervix was not dilated enough to advance the jada.A mdr will be filed for this case out of an abundance of caution.

• 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: 13723970
• MDR Text Key: 286961776
• Report Number: 3017425145-2022-00029
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: No
• 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: 02/09/2022
• 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 Sex: Female