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

Model Number	JADA 01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
This spontaneous report originating from united states was received from a nurse via company representative, referring to a female patient of unknown age.The patient historical conditions include pregnancy and delivery.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).Reporter stated that the physician had placed vacuum-induced hemorrhage control system (jada system) (#1) and the patient continued to have significant bleeding (device ineffective), especially noted vaginally around the cervical seal (vaginal haemorrhage).That vacuum-induced hemorrhage control system (jada system) (#1) was removed, and another vacuum-induced hemorrhage control system (jada system) (#2) was placed, with the same issue (post-partum hemorrhage) and significant bleeding vaginally around the seal (device ineffective and vaginal haemorrhage).Bleeding continued, vacuum-induced hemorrhage control system (jada system) (#2) was removed, and patient went to interventional radiology for treatment.It was reported that the bleeding controlled after embolic material placed.The nurse did not know quantification of blood loss (qbl) and the package was not saved and stated that was likely a vacuum-induced hemorrhage control system (jada system) 1.0 since this facility had existing stock of 1.0 and no 2.0 in-house.Also reported that the patient sought medical attention.It was also reported that the reporter had limited information to provide.The availability of vacuum-induced hemorrhage control system (jada system) (#1) and vacuum-induced hemorrhage control system (jada system) (#2) was considered as not available (package was not saved).The events of device ineffective was considered to be serious as it required an intervention.Medical device reporting criteria: serious injury.(b)(4).

• 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: 15705014
• Report Number: 3017425145-2022-00148
• Device Sequence Number: 17376523
• 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
• Operator of Device: Health Professional
• Device Model Number: JADA 01
• Device Catalogue Number: JADA-1001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2022
• 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
• Patient Sex: Female