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	Insufficient Information (4580)
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 physician via clinical account specialist (cas) (company representative), referring to a female patient of unknown age.The patient's concurrent conditions, concomitant medications and past drug reactions/allergies were not reported.The patient's medical history included pregnancy and had delivery.This report concerns 1 patient and 1 device.On an unknown date, the patient had vacuum-induced hemorrhage control system (jada system) insertion via vaginal route (lot# and expiration date were not reported) by physician for post-partum hemorrhaging (postpartum haemorrhage).It was reported that there was no device issue, but vacuum-induced hemorrhage control system (jada system) did not control bleeding (device ineffective) for the patient.Due to unsuccessful in controlling bleeding, the patient ended up with bakri balloon.On an unknown date, therapy with vacuum-induced hemorrhage control system (jada system) was discontinued.The patient sought medical attention.It was reported that vacuum-induced hemorrhage control system (jada system) came with blue seal valve.The physician stated that of the 20 vacuum-induced hemorrhage control system (jada system) they had used and four (4) of them were unsuccessful in controlling bleeding (used in four different patients).Upon internal review, the event of "device ineffective" was determined to be serious due to required intervention (devices).This was one of the four reports received from the same reporter.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: 15374302
• Report Number: 3017425145-2022-00139
• Device Sequence Number: 5809444
• Product Code: OQY
• UDI-Device Identifier: 00850017882003
• UDI-Public: (01)00850017882003
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/07/2022

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
• Operator of Device: Health Professional
• Device Model Number: JADA-1001
• Device Catalogue Number: JADA-1001
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 09/07/2022
• 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
• Patient Sex: Female