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

Model Number JADA-1001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Type  Injury  

Manufacturer Narrative

Based on the information we have received, there is no indication that the device malfunctioned.The device is assembled according to specifications.In process and finished product testing are performed and approved prior to release.

Event Description

This initial spontaneous report originating from the united states was received from a physician via employee referring to a female patient of unknown age.Patient delivered twins on an unknown date in (b)(6) 2022 (reported as approximately 2 weeks ago) (unknown delivery method).Information regarding the patient's other medical history, concurrent conditions and concomitant medications were not provided.This report concerns 1 device and 1 patient.On an unknown date in (b)(6) 2022, the patient was inserted with vacuum-induced hemorrhage control system (jada system) via vaginal route (lot# and expiration date were not reported) for post-partum hemorrhaging.Employee stated that vacuum-induced hemorrhage control system (jada system) was unable to control bleeding (device ineffective) as they "could not get the device to stay in place" (device expulsion).After vacuum-induced hemorrhage control system (jada system) was removed, bakri balloon (also reported as bakri uterine balloon) was inserted.Employee had extremely limited details and had reached out to the customer via email for additional details.No additional information available at that time.The availability of vacuum-induced hemorrhage control system (jada system) was unknown.The event device ineffective was considered as serious as it required intervention with an escalating treatment.Upon internal review, the event of "device expulsion" was determined to be medically significant.Medical device reporting criteria: serious injury.Fda code: (b)(4).

• 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: 3495 edison way menlo park
• MDR Report Key: 15210163
• MDR Text Key: 297702593
• Report Number: 3017425145-2022-00132
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: JADA-1001
• Device Catalogue Number: JADA-1001
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/29/2022
• Initial Date FDA Received: 08/11/2022
• 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 Outcome(s): Other
• Patient Sex: Female