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 and a nurse via a sales representative, referring to a female patient of unknown age.This report concerns 1 patient and 1 device.This patient was described as multiparous.She had a spontaneous vaginal delivery and her postpartum hemorrhage (pph) started within one hour after delivery.Hence, she received carboprost trometamol (hemabate) (1 unit), misoprostol (cytotec) (1 unit) and methylergometrine maleate (methergine) (1 unit).The patient's blood loss was reported as 1000 milliliter (ml).The patient was also treated with uterotonics (unspecified) for pph, however it failed.The cervical seal was reported as filled with 60 ml of sterile fluid.On (b)(6) 2022, the patient was inserted with vacuum-induced hemorrhage control system (jada system), however it did not control the pph bleeding (device ineffective), and due to which the patient received a dilation and curettage (d&c), attempted bakri, and b lynch suture.On (b)(6) 2022, the nurse reported that, they did not retain the device and lot number.Further she reported that, it was just an unfortunate event, and it there was no fault of the vacuum-induced hemorrhage control system (jada system).The decision to use the device was made late in the hemorrhage and the patient ended up going into d&c.The event of device ineffective was considered to be serious as an intervention was required (dilation and curettage (d&c).(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: heather wisler ; 3495 edison way; menlo park, CA 94025 ; 8445232666
• MDR Report Key: 14366355
• MDR Text Key: 294673461
• Report Number: 3017425145-2022-00084
• 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: 05/11/2022

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: 04/11/2022
• Initial Date FDA Received: 05/11/2022
• 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 Sex: Female