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

Model Number JADA-1001

Device Problem Suction Failure (4039)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/03/2021

Event Type  Injury  

Manufacturer Narrative

It is unclear whether the jada malfunctioned based on the information that is 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

It was reported that a (b)(6) patient delivered and experienced a postpartum hemorrhage.Patient was treated with pitocin, hemabate, txa (tranexamic acid) and cytotec.After 1500ml blood loss, the md placed jada and no blood was being drawn through jada.The jada was removed and noted to be clotted.The physician removed any retained products and then troubleshooted by changing the suction tubing and flushing the jada device.There was no suction noted and the device was contaminated due to the patient experiencing diarrhea.The physician used another jada and noted "the same issues of not suctioning" and a bakri balloon was placed.The physician noted clots in the loop of jada upon removal.Total ebl at this time was 2500ml.No further escalation of care was noted.The patient subsequently recovered and was discharged home.

• 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: 11611675
• MDR Text Key: 245973185
• Report Number: 3017425145-2021-00008
• 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: 04/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JADA-1001
• Device Catalogue Number: JADA-1001
• Device Lot Number: 1048001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2020
• 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 Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Weight: 79