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

Model Number JADA - 1001

Device Problems Partial Blockage (1065); Suction Problem (2170)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

On (b)(6) 2022 alydia health/organon employee observed a facebook post in a private group of health care providers for women's health in an online conversation that mentioned the jada system.The facebook post was made on (b)(6) 2022 and stated, "we used it in a hemorrhage.Unfortunately our suction wasn't working properly and the blood congealed in the tube causing it not to work well.I think it would have worked great if the suction would have worked.It was very easy to use though." there is no further information currently, and no further information will be able to obtained for this case.We are unable to obtain additional information regarding this case, unable to confirm this is an hcp that has used jada, unable to confirm the site, and unable to investigate if the site had an issue with their wall suction or there was a device malfunction causing a suction issue.We will report this as a device malfunction out of an abundance of caution.

Manufacturer Narrative

Based on the overall information currently provided in this report, there is a reasonable possibility that a potential malfunction (reported as "suction wasn't working properly and the blood congealed in the tube causing it not to work well") 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, "signs of patient deterioration or failure to improve indicate the need for reassessment and possibly more aggressive treatment and management of postpartum hemorrhage (pph)/abnormal postpartum uterine bleeding.", "jada is not a substitute for surgical management and fluid resuscitation of life-threatening pph/abnormal postpartum uterine bleeding.", "precautions: after initiation of vacuum, blood flow into jada or the vacuum tubing and/or improvement in uterine tone should be noted.If this does not occur, the cervical seal and/or the vacuum may not be effective.", "troubleshooting: recommended actions (vacuum is not detected at the end of the vacuum tubing.): check connection on all system components and recommended actions (vacuum system is connected and working but uterus does not collapse and/or bleeding does not stop): increase vacuum pressure to maximum (90 mm hg), disconnect the vacuum tubing from jada and occlude the end of the tubing to check vacuum, confirm appropriate jada placement, with ultrasound if needed and re-evaluate patient for other sources of bleeding" out of an abundance of caution, the company will report this as a malfunction mdr.

• 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: 14150684
• MDR Text Key: 298889086
• Report Number: 3017425145-2022-00066
• 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: Other
• Type of Report: Initial
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 03/24/2022
• 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