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

Model Number JADA - 1001

Device Problems Improper or Incorrect Procedure or Method (2017); Expulsion (2933)

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

Event Type  malfunction  

Manufacturer Narrative

Based on the overall information currently provided in this report, there is a reasonable possibility that a potential malfunction (reported as " they feel that it is more likely to expel with less fluid in the seal" and mention of "past expulsion with coughing") has occurred with the jada system whereby if the suspected malfunction were to recur at a time when the patient was not under close observation, this malfunction could possibly cause or contribute to a death or serious injury.Of note, the assessment is confounded by the reported coughing in one patient (known to be associated with increase in intra-abdominal pressure).However, the limited information provided regarding details of the expulsion precludes a complete and meaningful assessment.This report will be amended as appropriate if additional information is received.Per the jada system ifu "note: confirm that the cervical seal is positioned at the external cervical os after the system is in place (cervical seal is filled and the vacuum is connected).Reposition jada if required to facilitate a seal.", "precaution: ensure jada is secured with tape to avoid unintentional dislodgement", "jada preparation; fill sterile luer tapered syringe with 60 ml of sterile fluid." and "filling of cervical seal and connection of vacuum: while securely holding the seal valve and avoiding unintentional proximal or distal movement of the cervical seal away from the external cervical os, use a sterile luer tapered syringe to fill the cervical seal with 60 ml of sterile fluid.If needed, add up to another 60 ml of sterile fluid to achieve coverage of the external cervical os and create a seal for vacuum." out of an abundance of caution, this case will be reported as a malfunction mdr.

Event Description

On (b)(6)2022 alydia health employee shared an email stating, "i was talking with a doctor from xx yesterday and she said that she and many of the docs at main campus regularly fill the cervical seal with 200ml.She said they feel that it is more likely to expel with less fluid in the seal so to ensure that it doesn't, they just go with 200 as a standard now.Just thought i'd share that feedback with you all." the health care provider also mentioned in passing hearing about a past "expulsion with coughing." there is limited information for this report.A request for additional information was made on 02/25/2022, and 02/28/2022 for follow up information regarding this case.The health care provider for this case declined to provide any further information for this and refused any follow up communication and requested to be anonymous regarding this case.A good faith effort has been made to obtain additional information.

• 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: 13892164
• MDR Text Key: 287844507
• Report Number: 3017425145-2022-00039
• 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: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• 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: 02/23/2022
• 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