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 Date 10/24/2021

Event Type  Injury  

Event Description

The patient was reported to have preeclampsia with severe features this pregnancy, gestational hypertension, and uterine fibroids.She presented for delivery of a singleton at 35.3 weeks and received oxytocin for induction of labor.Induction was scheduled due to an intractable headache.She received magnesium sulfate therapy that was discontinued early due to hypotension.She received an epidural and spinal anesthesia for labor.The patient was noted to have abnormal postpartum bleeding related to uterine atony.Prior to jada insertion, the patient received txa (1 dose), carboprost (1 dose), and misoprostol.The patient's cumulative estimated blood loss at the time of jada insertion was reported at 1700 ml.Jada was inserted and in-dwelling for 10 minutes.Bleeding was noted as not controlled after jada placement.The patient then had bakri treatment following jada removal.She received red blood cells (2 units) and fresh frozen plasma (1 unit) after jada was removed.

Manufacturer Narrative

The post-jada medical interventions were necessary due to the patient's severe pph which was pre-existing prior to the use of jada.As we are unable to rule out the use of jada in contributing to the need for the subsequent interventions, we are reporting this as a mdr in an abundance of caution.

• 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: richard ferrick ; 3495 edison way; menlo park, CA 94025 ; 8445232666
• MDR Report Key: 13030546
• MDR Text Key: 286497668
• Report Number: 3017425145-2021-00037
• 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: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• 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
• Date Manufacturer Received: 11/18/2021
• 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
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 119 KG
• Patient Race: Black Or African American