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

Model Number JADA - 1001

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946)

Event Date 07/06/2021

Event Type  Injury  

Manufacturer Narrative

To the questions on the report asking, "did the patient experience a device or procedure related ae?" and "did the patient experience an sae, related or unrelated?", the answers were checked "no".Lot number is not available for this event.A request was sent to this site for lot number, the response to this request was that this site does document jada lot numbers.A good faith effort to obtain lot number has been attempted.This report will be amended if we receive additional information regarding this event.Per the jada system ifu "evaluate for lacerations, retained products of conception, or other causes of bleeding prior to using jada." and "jada is not a substitute for surgical management and fluid resuscitation of life-threatening pph/abnormal postpartum uterine bleeding." 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 surgical intervention to preclude permanent body damage/impairment.The assessment of the uncontrolled abnormal postpartum uterine bleeding is impacted by the confounding factor consisting of the reported retained placenta which required escalating treatment involving dilatation and curettage procedure.Out of an abundance of caution, the company will continue to report this case as a serious injury mdr.

Event Description

In response to the question on the ruby study case report form (crf) about whether jada controlled abnormal postpartum uterine bleeding or hemorrhage, the answer was checked "no." the patient was treated with a dilatation and curettage (d&c) to remove retained placenta that was found after jada treatment was initiated.The subject of this report is a (b)(6) woman, g5p5, race reported as white.She has a prior history of abnormal postpartum uterine bleeding or hemorrhage with two prior pregnancies, both treated with uterotonics.Her medical history for the pregnancy in this case was significant for chronic anemia and chronic hypertension.She presented for an induction and vaginal delivery of one infant at 39 weeks.She received oxytocin for (9) nine hours after deliver of the placenta.On admission, her height was noted as 165 cm, weight (b)(6), bmi 29.90, and hemoglobin (hgb) 11.1 g/dl.Her hgb at discharge was noted at 8 g/dl.She received epidural anesthesia for delivery, the infant weighed (b)(6) grams.The subject was noted to have pph related to uterine atony and retained placenta after delivery.The crf noted "unknown" if there was lower uterine segment (lus) bleeding involved in this event for the question asking about lus involvement.Prior to the attempt at jada insertion, the patient received misoprostol and one dose of txa.The patient's cumulative estimated blood loss at the time of jada insertion was reported as "unknown." jada was noted to be inserted on (b)(6) 2021, in the labor and delivery unit (l&d), (4) four minutes after placenta delivery and the in-dwelling time of jada was noted as 1.83 hours.The total amount of blood collected in the jada canister was noted as "unknown." the time from vacuum connection to control of abnormal bleeding with jada was reported as "unknown." this jada was removed due to continued bleeding and the patient was taken to the operating room (or) for a d&c to removed retained placenta.Following the d&c, a second jada was inserted and controlled the patient's bleeding.There is no report on blood collected or in-dwelling time with this second device.Total blood loss for the event was reported as 2988 ml.

• 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: 13537205
• MDR Text Key: 290372934
• Report Number: 3017425145-2022-00008
• 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: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• 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: 34 YR
• Patient Sex: Female
• Patient Weight: 81 KG
• Patient Race: White