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 Necrosis (1971); Insufficient Information (4580)

Event Type  Injury  

Event Description

This spontaneous report was received from a nurse (reported as research nurse) via company representative (reported as clinical educator) regarding a female patient of unknown age.The patient's historical conditions considered included pregnancy, delivery.The patient's concomitant medications, and drug reactions/allergies were not reported.This report concerns 1 patient and 1 device.On an unknown date, the patient underwent insertion procedure with vacuum-induced hemorrhage control system (jada system) via vaginal route (defaulted route) (strength, lot# and expiration date were not reported) for bad hemorrhage (postpartum haemorrhage) along with many other unspecified interventions.On an unknown date, the patient's uterus eventually became necrotic (uterine necrosis) and had to be removed.The reporter stated that she was performing root cause analysis on this patient.When the reporter performed further analysis to see if any other patients had similar issues, she identified another 4 patients, another 1 of whom had a vacuum-induced hemorrhage control system (jada system) placed.No additional information was provided.The outcome of the event was unknown.The causality assessment was not provided.Upon internal review, the event uterine necrosis was determined to be medically significant.Upon internal review, event uterine necrosis was considered to be serious due to required intervention (devices).This is one of 2 reports received from the same reporter.Medical device reporting criteria: serious injury.(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, ca; CA 94025
• Manufacturer (Section G): ALYDIA HEALTH; 3495 edison way menlo park, ca; CA 94025
• Manufacturer Contact: 3495 edison way menlo park, ca
• MDR Report Key: 15705126
• MDR Text Key: 302763194
• Report Number: 3017425145-2022-00146
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: JADA-1001
• Device Catalogue Number: JADA-1001
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2022
• 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): Required Intervention; Other
• Patient Sex: Female