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

Model Number JADA - 1001

Device Problem Obstruction of Flow (2423)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/26/2022

Event Type  malfunction  

Event Description

Alydia health received a completed jada experience survey form that reported "clots were removed before jada was placed, suction did not work when attached, jada was removed.And clots were blocking the vacuum pores.Replaced after clots removed" in the area on the survey designated for feedback when 'jada did not stop bleeding'.The information provided for this event was received from the survey and a follow up email from the site, it is limited in detail.The patient in this case is described as experiencing abnormal postpartum uterine bleeding that started within one hour after an induced vaginal delivery with forceps assistance.Prior to jada treatment she received no medications to treat abnormal postpartum uterine bleeding.Her blood loss prior to jada use was noted as 400 ml.There is a note of pitocin, greater that twelve (12) hours on the survey, timing of this was not noted or clarified by this site.The health care provider performed a manual sweep, a jada system was placed, and the cervical seal was filed with 120 ml of sterile fluid.The staff reported difficulty with the wall suction in the patient room and it was reported to that "it took a few minutes to obtain the necessary regulator, etc." they report not knowing the length of time from manual sweep to vacuum initiation.After the vacuum was connected, they noted the jada as "clogged." the device was removed, clots were cleared from the vacuum pores, and they reinserted the jada and initiated vacuum.They reported the jada as then working "successfully" and bleeding stopped within one minute.The total blood loss for this case was reported as 500 ml.

Manufacturer Narrative

Based on the overall information currently available in this report, there is no clear evidence that the reported events of suction not working (reported as "suction did not work when attached") and clot blockage of the vacuum pores (reported as "clots were blocking the vacuum pores") are a result of a potential malfunction.The pre-existing blood clots (reported as "clots were removed before jada was placed") prior to jada system placement appears to provide a more plausible alternative explanation for these events.It appears that following clot removal from the vacuum pores, jada reportedly worked successfully on 2nd attempt (also reported as "replaced after clots removed").Further, the hcp would recognize this issue and would be able to take appropriate action.However, out of an abundance of caution, the company will report this case 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: 13588232
• MDR Text Key: 290441934
• Report Number: 3017425145-2022-00014
• 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: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• 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
• Device Lot Number: 1070801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2021
• 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