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

Model Number JADA - 1001

Device Problems Obstruction of Flow (2423); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

An unknown health care provider (hcp) who used the jada device reported to their sites director (unknown hcp as well) regarding a case that a jada device was utilized.The details were very vague and there is an unsure timeline of events.The director stated the jada was placed in a patient who then needed interventional radiology (ir).The patient then went back to the or, a d&c was done, and another jada was placed.Per the director the provider felt like jada was "clogged" and an ultrasound showed clots.This patient's treatment progressed to hysterectomy.This site has not responded to multiple requests regarding lot number, device retention, or additional details for this case.A good faith effort has been made to obtain this information.A jada device was inserted to stop postpartum bleeding.The patient's treatment continued to ir, a d&c, a second jada.The second jada was reported to be "clogged" with clots.The patient's care then progressed to hysterectomy.As we are unable to rule out the use of jada in contributing to the need for the previous interventions or a device malfunction, we are reporting this as a mdr in an abundance of caution.

Manufacturer Narrative

Based on the overall information currently available for this report, a possible contributing or causal role of the jada system for the need of escalating interventions (d&c [1st jada device] and hysterectomy [2nd jada device]) to preclude permanent body damage/impairment cannot be excluded.Based on the overall information currently provided in this report, there is a reasonable possibility that a potential malfunction (reported as "clogged") 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.The limited information provided in this case precludes a complete and meaningful assessment.This report will be amended as appropriate if additional information is received regarding the event.Per the jada system ifu, "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.", "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." out of an abundance of caution, the company will report this case as a serious injury and 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: 14243915
• MDR Text Key: 299314235
• Report Number: 3017425145-2022-00075
• 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: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: Yes
• 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: 04/01/2022
• 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): Other
• Patient Sex: Female