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

Model Number JADA-1001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

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 Description

This initial spontaneous report originating from the united states was received from a physician via a company representative, referring to a non pregnant female patient of unknown age.This report concerns 1 patient and 1 device.The patient's drug reactions/allergies and concomitant medications were not reported.The patient had 3 caesarean sections in the past and recently had one more caesarean section (fourth).On (b)(6) 2022, the physician used a vacuum-induced hemorrhage control system (jada system) (lot number reported as 1075201 and serial number was not provided) for the first time on a patient that was hemorrhaging (postpartum haemorrhage) after her fourth caesarean section.Physician reported that on (b)(6) 2022, the vacuum-induced hemorrhage control system (jada system) worked well for an undisclosed amount of time and then the patient began bleeding heavily again (device ineffective).Provider then performed a hysterectomy, and the patient was admitted to intensive care unit (icu) (hospitalization).On (b)(6) 2022, therapy with vacuum-induced hemorrhage control system (jada system) was discontinued.The availability of vacuum-induced hemorrhage control system (jada system) was unknown.The event of device ineffective was considered to be serious as it required an intervention.Medical device reporting criteria: serious injury.(b)(4).

Event Description

This initial spontaneous report originating from the united states was received from a physician via a company representative, referring to a non pregnant female patient of unknown age.This report concerns 1 patient and 1 device.The patient's drug reactions/allergies and concomitant medications were not reported.The patient had 3 caesarean sections in the past and recently had one more caesarean section (fourth).On (b)(6) 2022, the physician used a vacuum-induced hemorrhage control system (jada system) (lot number reported as 1075201 and serial number was not provided) for the first time on a patient that was hemorrhaging (postpartum haemorrhage) after her fourth caesarean section.Physician reported that on (b)(6) 2022, the vacuum-induced hemorrhage control system (jada system) worked well for an undisclosed amount of time and then the patient began bleeding heavily again (device ineffective).Provider then performed a hysterectomy, and the patient was admitted to intensive care unit (icu) (hospitalization).On (b)(6) 2022, therapy with vacuum-induced hemorrhage control system (jada system) was discontinued.The availability of vacuum-induced hemorrhage control system (jada system) was unknown.The event of device ineffective was considered to be serious as it required an intervention.Medical device reporting criteria: serious injury.Fda code: (health effects - health impact per annex f): 4625 additional surgery (surgical intervention that was not planned and needed to be performed in addition to other interventions including surgical ones).Follow-up information was received on 12-sep-2022.Expiration date of the suspect product vacuum-induced hemorrhage control system (jada system) was reported as 29-oct-2025 (previously not reported).

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
• Type of Device: 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: 15210164
• MDR Text Key: 297701499
• Report Number: 3017425145-2022-00130
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 00850017882003
• UDI-Public: (01)00850017882003
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/16/2022

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 Operator: Health Professional
• Device Model Number: JADA-1001
• Device Catalogue Number: JADA-1001
• Device Lot Number: 1075201
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2022
• Initial Date FDA Received: 08/11/2022
• Supplement Dates Manufacturer Received: 09/12/2022
• Supplement Dates FDA Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female