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

Model Number	JADA-1001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Necrosis (1971); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem 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).
Additional 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
• Common Device Name: 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
• Report Number: 3017425145-2022-00146
• Device Sequence Number: 20479036
• Product Code: OQY
• UDI-Device Identifier: 00850017882003
• UDI-Public: (01)00850017882003
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/31/2022

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Female