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 Problem 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 spontaneous report was received from a female patient of unknown age referring to herself, via company representative.The patient's historical condition included cesarean section.The patient's concurrent conditions, concomitant medications, and past drugs/allergies were not reported.This report involves 1 patient and 1 device.On (b)(6) 2022, the patient was inserted with vacuum-induced hemorrhage control system (jada system) (strength, lot# and expiration date were not reported) for atony related bleeding.The patient had atony related bleeding postoperative cesarean section, which was in recovery, blood loss was about 2400 milliliter (ml).When vacuum-induced hemorrhage control system (jada system) was placed in the operation room (or).The patient then continued to bleed with vacuum-induced hemorrhage control system (jada system) in place and on vacuum, with a return of about 1600 ml more blood (device ineffective).The patient then had a hysterectomy to control bleeding and received multiple doses of blood products.The patient body mass index (bmi) was 48 (units not reported).The patient sought medical attention.Estimated total blood loss at delivery was reported as 4000 ml.Upon internal review, the event device ineffective was determined to be serious due to medically significant and required intervention (devices).Medical device reporting criteria: serious injury.(b)(4).

• 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: 15080306
• MDR Text Key: 296374771
• Report Number: 3017425145-2022-00121
• 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: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/21/2022

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
• Device Model Number: JADA-1001
• Device Catalogue Number: JADA-1001
• Initial Date Manufacturer Received: 06/24/2022
• Initial Date FDA Received: 07/21/2022
• 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): Required Intervention; Other
• Patient Sex: Female