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 originating from united states was received from a physician via a registered nurse and a sales representative, referring to a female patient of unknown age.This report concerns 1 patient and 1 device.On an unknown date approximately in (b)(6) 2022 (reported as 'over the weekend'/'exact date unknown'), the physician was caring for a patient who had been consistently bleeding and was on oxytocin (pitocin).The patient was treated with uterotonics (unspecified), however it failed to stop postpartum uterine bleeding.The physician completed a sweep utilizing instruments to remove clots.She then attempted to place a vacuum-induced hemorrhage control system (jada system) approximately four hours after delivery and was unable to 'due to the angle of the uterus' (complication of device insertion).The patient's bleeding stopped due to uterotonics given and no further action was needed.It was reported that, the patient's treatment continued additional uterotonics (unspecified).Medical device reporting criteria: serious injury.(b)(4).Unexpected medical intervention (patient required an unforeseen medical intervention, excluding surgery, which was not on the original treatment plan.).

• 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: heather wisler ; 3495 edison way; menlo park, CA 94025 ; 8445232666
• MDR Report Key: 14375433
• MDR Text Key: 291512446
• Report Number: 3017425145-2022-00091
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/12/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2022
• Initial Date FDA Received: 05/12/2022
• 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
• Treatment: 1) PITOCIN [OXYTOCIN] (OXYTOCIN)
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic