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

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

Patient Problem Insufficient Information (4580)

Event Date 10/25/2023

Event Type  Injury  

Event Description

The patient was going to radiology for a possible uterine artery embolization, and the caller was asking if there was any contraindication to leaving jada in place during the procedure.[device ineffective] case narrative: this initial spontaneous report originating from the united states was received from a physician via rocky mountain poison and drug safety (rmpds) and company representative, referring to a female patient of unknown age.The patient's medical history, concurrent conditions, past drugs, allergies and concomitant medications were not reported.This report concerned 1 patient and 1 device.On (b)(6) 2023, the patient was inserted with vacuum-induced hemorrhage control system (jada system) via an unknown route by the physician for presumably postpartum hemorrhage.However, the patient was going to radiology for a possible uterine artery embolization, and the physician was asking if there was any contraindication to leaving the device in place during the procedure (device ineffective).The physician was advised that this was not a contraindication, and that device was compatible with imaging studies such as ultrasound, computed tomography (ct) scan and magnetic resonance imaging (mri).No additional information was available.It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.For vacuum-induced hemorrhage control system (jada system), lot number and serial number were not provided.Upon internal review, the event of device ineffective was determined to be serious due to required intervention.Medical device reporting criteria: serious injury.When the lot number is unknown, a technical investigation of the specific manufacturing process which includes review of records associated with a known lot number cannot be performed.

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; 94025
• Manufacturer (Section G): ORGANON & CO.; 30 hudson street; jersey city NJ 07302
• Manufacturer Contact: 30 hudson street; jersey city, NJ 07302
• MDR Report Key: 18159692
• MDR Text Key: 328400123
• Report Number: 3017425145-2023-00005
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 510K K201199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/17/2023

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?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/17/2023
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female