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

Model Number JADA - 1001

Device Problem Obstruction of Flow (2423)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  malfunction  

Event Description

A health care provider using the jada system for the first time reported via email that "plaed" a jada after clearing uterine clots, performed an ultrasound and observed a thin endometrial stripe and noted "minimal blood in the tubing and no clear bleeding around the seal" and "thought it was working." she reported removing the device 1.5 hours later and observed "clot obscuring the holes" and 50-75% of the holes were occluded by clot." she noted the "patient did hae an additional 300 ml of clot inside the uterus." the patient received two units of packed red blood cells following treatment with jada.The health care provider did not respond to the request for additional information regarding this case.

Manufacturer Narrative

Although the case is confounded by the reported blood clots, based on the overall information currently provided in this report, there is a reasonable possibility that a potential malfunction (reported as "clot obscuring the holes" and "50-75% of the holes were occluded by clot") has occurred with the jada system whereby if the suspected malfunction were to recur at a time when the patient was not under close observation, this malfunction could possibly cause or contribute to a death or serious injury.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 "and "signs of patient deterioration or failure to improve indicate the need for reassessment and possibly more aggressive treatment and management of postpartum hemorrhage (pph)/abnormal postpartum uterine bleeding." out of an abundance of caution, this case will be reported as a malfunction 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: 14090667
• MDR Text Key: 294955240
• Report Number: 3017425145-2022-00059
• 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: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 03/15/2022
• 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