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 originating from united states was received from a physician via medical science liaison, referring to a female patient of unknown age.The patient had delivered twins.The patient's concurrent conditions, past drugs/allergies, and concomitant medications were not reported.This report concerns 1 patient and 2 devices.On an unknown date, the patient used vacuum-induced hemorrhage control system (jada system) (#1) via vaginal route (strength, frequency, lot# and expiration date were not reported) for postpartum haemorrhage (post-partum hemorrhage).The device fell out (device expulsion) and a new vacuum-induced hemorrhage control system (jada system) (#2) was placed, via vaginal route (strength, frequency, lot# and expiration date were not reported) for postpartum haemorrhage (post-partum hemorrhage), however, the second device also fell out (device expulsion).At that time, a bakri balloon was initiated which did not control bleeding and as a result, the events resulted in a hysterectomy for the patient.The vacuum-induced hemorrhage control system (jada system) did not control bleeding (device ineffective).It was also reported that the reporter had limited information to provide as this was not her patient and was a case she heard about.The availability of vacuum-induced hemorrhage control system (jada system) (#1) and vacuum-induced hemorrhage control system (jada system) (#2) was unknown.The events of device ineffective and device expulsion were considered to be serious as they required an intervention.Upon internal review, the events of device expulsion was determined to be medically significant.(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; 2157313727
• MDR Report Key: 15633114
• Report Number: 3017425145-2022-00145
• Device Sequence Number: 7941532
• Product Code: OQY
• UDI-Device Identifier: 00850017882003
• UDI-Public: (01)00850017882003
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 10/19/2022

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: 10/07/2022
• Initial Report FDA Received Date: 10/19/2022
• 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; Required Intervention
• Patient Sex: Female