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 07/04/2021

Event Type  malfunction  

Manufacturer Narrative

The user facility did not allege that the device caused or contributed to patient injury.Jada expulsion was likely secondary to "aggressive coughing" as reported by the facility.It is unclear if the jada device 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.

Event Description

A jada device was expelled when a patient had a vigorous episode of coughing and a second device was placed and was effective.Upon further inquiry, additional information was gathered and it was noted that the expelled device was quickly replaced however, the ob was not confident that the jada was in the correct location but that bleeding appeared to have stopped.Shortly after the first device was replaced, bleeding was again noted and the device was removed and it was noted that the device appeared to be "folded" or "turned in on itself".The patient was brought back to the or where they removed blood clots from the uterine cavity and placed a 2nd jada device under ultrasound guidance and found that bleeding was controlled and no further treatment for bleeding was needed.

• 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: 12305313
• MDR Text Key: 266065537
• Report Number: 3017425145-2021-00014
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• 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
• Device Lot Number: 1054902
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2021
• 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
• Treatment: CYTOTEC; HEMABATE; METHERGINE; PRBC - 3 UNITS; TXA
• Patient Age: 30 YR
• Patient Weight: 79