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 Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
This spontaneous report was received from a nurse manager via clinical educator (company representative) referring to a patient of unknown age and gender.Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications were not provided.This report concerns 1 device and 1 patient.On an unknown date, the patient underwent insertion procedure with vacuum-induced hemorrhage control system (jada system) (strength, route of administration, lot# and expiration date were not reported) for an unknown indication.On an unknown date, bedside nurse discontinued the suction, but did not deflate the cervical seal immediately.The cervical seal was left in place for about 2 hours and then the bedside nurse tried to flush the vacuum-induced hemorrhage control system (jada system) tube because a clot formed in the vacuum-induced hemorrhage control system (jada system) tube (wrong technique in device usage process and device occlusion).The device was removed and bleeding did not reoccur.No additional information was provided at the time of reporting.Upon internal review, the event of wrong technique in device usage process and device occlusion were determined to be medically significant.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 94025
• Manufacturer (Section G): ALYDIA HEALTH; 3495 edison way menlo park,; CA 94025
• Manufacturer Contact: 3495 edison way menlo park
• MDR Report Key: 15495952
• Report Number: 3017425145-2022-00141
• Device Sequence Number: 6090866
• Product Code: OQY
• UDI-Device Identifier: 00850017882003
• UDI-Public: (01)00850017882003
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/21/2022

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
• Operator of Device: Health Professional
• 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: 09/09/2022
• Initial Report FDA Received Date: 09/28/2022
• 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: Other
• Patient Sex: Unknown