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	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
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 was received from a physician who assisted during vacuum-induced hemorrhage control system (jada system) use via company representative (reported as clinical account manager) referring to a female patient of unknown age.The patient's historical conditions included pregnancy and cesarean section (c/s) delivery.Patient lost 2200 cubic centimeter (cc) of blood prior to vacuum-induced hemorrhage control system (jada system) being inserted.The patient's concomitant medications, and drug reactions/allergies were not reported.This report concerns 1 patient and 1 device.On (b)(6) 2022, 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 postpartum haemorrhage (reported as 2200 cc of blood lost prior to vacuum-induced hemorrhage control system (jada system) being inserted).Placement of vacuum-induced hemorrhage control system (jada system) was confirmed with ultrasound.On (b)(6) 2022 (also reported as occurred overnight on (b)(6) 2022), once vacuum-induced hemorrhage control system (jada system) was placed, the patient continued to bleed heavily and lost 1400 cc further until vacuum-induced hemorrhage control system (jada system) was discontinued on (b)(6) 2022, 15 minutes after insertion (device ineffective).The reporter did say that she saw the suction regulator reading 60 millimeters of mercury (mm hg) and suggested they turn the suction up, but the tech said the canister was being forcefully sucked in and felt the suction may have been "up all the way" (wrong technique in device usage process).The patient had a hysterectomy to control postpartum haemorrhage.No additional information was provided at the time of report.Upon internal review, the events of "device ineffective" and "wrong technique in device usage process" were determined to be serious due to required intervention (devices).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: 15462677
• Report Number: 3017425145-2022-00140
• Device Sequence Number: 6880973
• 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: Physician
• 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: 09/22/2022
• 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