MAUDE Adverse Event Report: ALYDIA HEALTH JADA SYSTEM; INTRAUTERINE VACUUM CONTRACTION SYSTEM

Model Number JADA-1001

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/23/2021

Event Type  malfunction  

Manufacturer Narrative

The user facility did not allege that the device caused or contributed to patient injury or malfunctioned.Jada expulsion was likely secondary to vomiting as reported by the facility.No additional treatment for bleeding was required following the expulsion of the device.No injury or adverse events related to the expulsion of the device were reported.We do not believe that jada malfunctioned based on the information available at this time, but out of an abundance of caution and because we cannot rule it out at this time we are reporting this event due to the 30 day reporting deadline.If we become aware of additional information, we will supplement this report.The submission of this report is not an admission that the device caused or contributed to the reported event.

Event Description

The patient was noted to have abnormal postpartum bleeding related to uterine atony after her delivery.Prior to jada insertion she received carboprost (1 dose), methergine (1 dose), and misoprostol.Estimated blood loss at time of jada insertion was noted as 600 ml.The report states jada was inserted, and 10 minutes after treatment was initiated, the patient vomited and expelled the device.The total amount of blood collected in the vacuum canister was noted as 20 ml.The report stated that, "the fundus was determined to be firm without additional bleeding, therefore the team determined not to re-insert the jada device." the total cumulative blood loss for this event was reported at 620 ml and bleeding was controlled.The patient was also reported as having received intrapartum antibiotics as she was positive for group b strep (gbs).

• 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: 12921943
• MDR Text Key: 285062605
• Report Number: 3017425145-2021-00029
• 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: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 11/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2021
• 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 Age: 21 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American