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

Model Number JADA-1001

Device Problem Suction Problem (2170)

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

Event Date 11/10/2021

Event Type  malfunction  

Event Description

Prior to jada insertion, manual evacuation of the patient's uterus was performed and an ultrasound found no retained products of conception.The delivery involved a large infant, approximately 10 (ten) pounds.The patient had a prior history of delivery of large infants as well.The hemorrhage was immediate after delivery.Multiple uterotonics were administered prior to jada insertion.When they inserted jada, 120 cc was used to fill the cervical seal.The patient was described as having global atony and it was reported that the jada worked "right away everything clamped down." at that point, it was reported that the suction tubing appeared to be clogged or clotted and trouble-shooting measures were taken.Repeated disconnection and clearing of the tubing was performed (estimated four times).After an hour of initial jada treatment, the verification steps were followed and indicated that bleeding was controlled.It was decided to leave jada in for about 12 more hours, overnight.At removal, the postpartum hemorrhage remained successfully controlled.No additional measures were required for treatment of this patient's pph after jada was used.

Manufacturer Narrative

Jada successfully treated this patient's postpartum hemorrhage, despite the report that the suction tubing for jada seemed clotted or clogged.Out of an abundance of caution, this potential malfunction is being reported because we cannot completely rule out that a similar malfunction could contribute to a death or serious injury if it were to recur.

• 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: 13015125
• MDR Text Key: 286853347
• Report Number: 3017425145-2021-00033
• 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: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• 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: 11/15/2021
• 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
• Patient Weight: 79 KG