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

Model Number JADA - 1001

Device Problem Insufficient Information (3190)

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

Event Date 03/23/2022

Event Type  malfunction  

Manufacturer Narrative

Based on the overall information currently available for this report, a possible contributing or causal role of the jada system to the reported occurence ("didn't work") cannot be excluded.The limited information provided precludes a complete and menaingful assessment.This report will be amended as appropriate if additional information is received.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.", "evaluate for lacerations, retained products of conception, or other causes of bleeding prior to using jada." and "jada is not a substitute for surgical management and fluid resuscitation of life-threatening pph/abnormal postpartum uterine bleeding." out of an abundance of caution, the company will report this case as a serious injury mdr.

Event Description

Alydia health received a completed jada experience survey form on 04/05/2022 that reported jada stopped the postpartum hemorrhage (pph) but noted "jada clotted during 30 minute obs.; had clots when try to restart" in the area on the survey designated for feedback when 'jada did not stop bleeding'.The event date for this survey was (b)(6) 2022.The information provided for this event was received from the survey and a follow up email from the health care provider that used jada in this case.This patient is described as multiparous and having an induced vaginal delivery.Her pph started within one hour after delivery.Prior to jada use she received cytotec (1000 mcg, rectal), txa (1000 units) and methergine (0.2 units).The patient's blood loss prior to jada use reported as 200 ml.Jada was reported to have controlled the abnormal postpartum uterine bleeding due to uterine atony in "1 - 5 minutes." the hcp for this case responded to the follow up questions.He stated, "this was the first time that myself and another provider used the jada.The jada worked well while connected to the suction.We left it connected for 90 mins.The blood loss was minimal but i don't remember the exact amount.The 30 mins observation period was performed and following this, there was some lochia on the patient's pad.The other provider was concerned about this lochia and that if the jada was removed, the patient would start bleeding again so i recommend that we connect it back to suction for some more time.However, the suction did not work because there was already clot in the proximal portion of the tubing.In the end, we removed the jada and no further bleeding was noted.It was just new user error." the hcp reported that they did not retain the jada in this case and that they did not record the lot number for this jada device.Following the attempt to treat postpartum uterine bleeding that uterotonics failed to treat, a jada device was inserted.The health care provider reported jada stopped the bleeding within one to five minutes, there was 100 ml in the jada canister; and "jada clotted during 30 minute obs.; had clots when try to restart." the hpc reported "user error" as the reason for restarting the suction and that the device functioned to stop the patient's bleeding and no further interventions were needed.We are reporting this as a mdr in an abundance of caution.

• 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: 14254906
• MDR Text Key: 290768251
• Report Number: 3017425145-2022-00080
• 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: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2022
• 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