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

Model Number	JADA-1001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
This spontaneous report was received from a company representative (clinical educator), referring to a female patient of unknown age.The patient's concurrent conditions, concomitant medications and past drug reactions/allergies were not reported.The primigravid patient had a spontaneous uterine inversion, which was corrected.This report concerns 1 patient and 1 device.It was reported that on an unknown date in (b)(6) 2022 (reported as about three days ago) the patient continued to bleed, so vacuum-induced hemorrhage control system (jada system) was inserted (lot# and expiration date were not reported) for post-partum hemorrhaging (postpartum haemorrhage) with quick control of bleeding.The patient was stable until she vomited (vomiting), and the vacuum-induced hemorrhage control system (jada system) was expelled (device expulsion) during active treatment with suction on at 80 millimeters of mercury (mmhg).She began to bleed heavily (heavy menstrual bleeding) and was taken to the operation room (or), where she was opened (reported as 'surgical intervention') (required intervention (devices)) , and it was found that her uterus had inverted again (uterine inversion), which was corrected and the bleeding was controlled.No product quality compliant (pqc) reported.On an unknown date in (b)(6) 2022, therapy with vacuum-induced hemorrhage control system (jada system) was discontinued.It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.Upon internal review, the events of device expulsion and uterine inversion were determined to be medically significant.Medical device reporting criteria: serious injury.(b)(4).

• Brand Name: JADA SYSTEM
• Common Device Name: 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: 15553597
• Report Number: 3017425145-2022-00143
• Device Sequence Number: 17632175
• Product Code: OQY
• UDI-Device Identifier: 00850017882003
• UDI-Public: (01)00850017882003
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/06/2022

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 Model Number: JADA-1001
• Device Catalogue Number: JADA-1001
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Female