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

Model Number JADA - 1001

Device Problem Expulsion (2933)

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

Event Date 01/26/2021

Event Type  malfunction  

Manufacturer Narrative

Although the reported device expulsion (reported as "initial control of postpartum bleeding but expelled with pt.Vomiting."") is confounded by the patient's vomiting episode (as increase intra-abdominal pressure), based on the overall information currently provided in this report, there is a reasonable possibility that a potential malfunction (reported as ""initial control of postpartum bleeding but expelled with pt vomiting."") 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.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." and "precaution: ensure jada is secured with tape to avoid unintentional dislodgement" out of an abundance of caution, the company will report this case as a malfunction mdr.

Event Description

Alydia health received a jada experience survey (jes) on (b)(6) 2022, that had a handwritten statement in the area designated for 'what treatment(s) did you use to treat the abnormal postpartum uterine bleeding that was not controlled with the jada system?' that stated, "initial control of postpartum bleeding but expelled with pt vomiting." the patient in this case is described as multiparous and obese.She had an unassisted, induced vaginal delivery and her abnormal postpartum uterine bleeding or pph started within one hour after delivery.Prior to jada treatment she received unknown doses of cytotec, hemabate, and one gram of txa.The amount of blood loss prior to jada use was not reported.The cervical seal was filled with 120 cc of sterile fluid.The amount of blood evacuated with jada was reported as 75 ml.There is no other information for this case provided on this survey.There is limited information for this jes.A request was sent to the site on (b)(6) 2022, (b)(6) 2022, and (b)(6) 2022, to inquire if the lot number was available, if the device was retained, and questions regarding this case.This case will be amended if additional information is received.

• 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: 13742277
• MDR Text Key: 294959459
• Report Number: 3017425145-2022-00031
• 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: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2022
• 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: 02/10/2022
• 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 Age: 30 YR
• Patient Sex: Female