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

Model Number JADA - 1001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Low Blood Pressure/ Hypotension (1914)

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 the escalating intervention hysterectomy) to preclude permanent body damage/impairment.The assessment is impacted by the confounding factors consisting of the pre-existing severe post-partum hemorrhage (estimated blood loss of 3000 ml) prior to jada system use as well as the reported blood clots removed during d&c procedure.Per the jada system ifu "evaluate for lacerations, retained products of conception, or other causes of bleeding prior to using jada.", "jada is not a substitute for surgical management and fluid resuscitation of life-threatening pph/abnormal postpartum uterine bleeding." however, out of an abundance of caution, the company will report this case as a serious injury mdr.

Event Description

Alydia health employee spoke via telephone to this sites quality director, a medical doctor, to follow up with the report of a "jada failure." this hcp stated they had a failure" and declined to provide some details of this case including specific date of case, patient initials date of birth/age, physician involved.He described the patient in this case as a primipara with a "difficult delivery, she pushed for 3 hours", two days post-partum after an unplanned cesarean section.She had a delayed postpartum hemorrhage (pph).Prior to jada treatment she was given pitocin and methergine (unknown doses) and "blood products" (unknown type and dose) the estimated blood loss (ebl) prior to jada was 3000 ml, which is severe pph.The patient was taken to the operating room (or) where she had a dilatation and curettage (d&c) where blood and clots were removed.A jada device was placed in the or where it was "working", the uterus was starting to firm and there was blood in the collection canister.The patient continued to receive blood products while jada was in place.The jada was in-dwelling for "two and half to three hours" and "200 to 300 ml" of blood was collected in the canister during that time.The patient appeared "hemodynamically unstable, hypotensive" and the decision was made to advance treatment to a hysterectomy.The patient did not appear to have dic.The hysterectomy stopped the patient's pph.Total blood loss for this case was unknown to this hcp.She received more blood products after the procedure and fully recovered.This hcp stated that the device was discarded after this case, and he later emailed to inform us that the site does not record lot numbers for any of the jada devices that are used.A good faith effort has been attempted to obtain the lot number for this case.

• 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: 13694845
• MDR Text Key: 286775567
• Report Number: 3017425145-2022-00025
• 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: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• 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: 02/07/2022
• 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 Outcome(s): Disability; Required Intervention
• Patient Age: 30 YR
• Patient Sex: Female