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 Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

This initial spontaneous report originating from the united states was received from a physician, referring to a female patient of unknown age.This report concerns 1 patient and 1 device.The patient's medical history, drug reactions/allergies and concomitant medications were not reported.On an unknown date, the patient used a vacuum-induced hemorrhage control system (jada system) (lot number and serial number were not provided) via intrauterine route for an unknown indication.Physician stated patient with vacuum-induced hemorrhage control system (jada system) in place was possibly pre-eclamptic and had seizures.Physician wanted to do a magnetic resonance imaging (mri) of the brain and asked if vacuum-induced hemorrhage control system (jada system) was mri compatible.Information for use (ifu)/ reference guide/ information request management system (irms) search yielded no results.No further information was known or available at the time of reporting.The outcome of the events was unknown.Causality was not reported.The availability of vacuum-induced hemorrhage control system (jada system) was no (device was in place).Upon internal review, the event seizure was determined to be medically significant.Medical device reporting criteria: serious injury.

Manufacturer Narrative

Based on the information we have received, there is no indication that the device malfunctioned.The device is assembled according to specifications.In process and finished product testing are performed and approved prior to release.

• 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: 3495 edison way menlo park
• MDR Report Key: 15210159
• MDR Text Key: 297700466
• Report Number: 3017425145-2022-00129
• 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: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: JADA-1001
• Device Catalogue Number: JADA-1001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2022
• Initial Date FDA Received: 08/11/2022
• 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