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 registered nurse via company representative referring to a female patient of unknown age.The patient's historical condition included pregnancy, placental abruption, emergency caesarian section, still birth at 39 weeks.This patient was in disseminated intravascular coagulation (dic) and had little clotting factors.Patient's concomitant medications were not reported.This report concerned 1 patient and 1 device.On an unknown date, the patient's uterus was repaired, and patient underwent insertion procedure with vacuum-induced hemorrhage control system (jada system) (strength, route, lot# and expiration date were not reported) to stop the bleeding (postpartum haemorrhage).Bleeding did not stop.Patient was at 2 liters of blood via vacuum-induced hemorrhage control system (jada system) before she went to intervention radiology.Vacuum-induced hemorrhage control system (jada system) was not gushing blood, but it was a slow trickle.Vacuum-induced hemorrhage control system (jada system) was troubleshot and rotated the device into a better position because there were suction issues at one point in the operating room (or) and the reporter thought it got moved (device ineffective).Reporter asked if dic is contraindicated for this type of device and wanted to know if all the blood from patient's vessels was pulled out knowing that she cannot clot.Reporter also asked if there was any study or finding that the uterus does not warp around the ring when it is in the position.The reporter was concerned about the position of the vacuum-induced hemorrhage control system (jada system), wanted to know what would happen if it gets vertical.She also stated that according to her the vacuum-induced hemorrhage control system (jada system) performed well (discrepant information).The availability of vacuum-induced hemorrhage control system (jada system) was unknown.Upon internal review, event device ineffective was considered to be serious due to required intervention (devices).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: 15503895
• Report Number: 3017425145-2022-00142
• Device Sequence Number: 18175945
• 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): 09/28/2022

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: 09/16/2022
• Initial Report FDA Received Date: 09/29/2022
• 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
• Patient Sex: Female