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 09/27/2022

Event Type  Injury  

Event Description

Jada device clotting at y-junction reducing intrauterine suction.Patient required emergent hysterectomy [device occlusion].Case narrative: information has been received from united states food and drug administration (us fda) (medical device report (mdr) number: mw5112776 on 27-oct-2022.This spontaneous report was received from a risk manager referring to a female patient of unknown age.The patient's medical history, concurrent conditions, concomitant medications and past drug reactions/allergies were not reported.This report concerns 1 patient and 1 device.On an unknown date, the patient was inserted with vacuum-induced hemorrhage control system (jada system) by healthcare professional (lot# and expiration date were not reported) for an unknown indication.On (b)(6) 2022, the vacuum-induced hemorrhage control system (jada system) device was clotted at y-junction and reduced the intrauterine suction and the patient required emergent hysterectomy (device occlusion).It was reported that the device was not reprocessed, and the vacuum-induced hemorrhage control system (jada system) was not available for investigation.The agency considered the event of device occlusion to be serious as it required intervention.(b)(4).

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: 16122097
• MDR Text Key: 306914394
• Report Number: 3017425145-2023-00001
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/09/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female