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

Model Number	JADA-2002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Insufficient Information (4580)
Date of Event	05/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient then started bleeding around the seal, so physician removed the jada [device ineffective].Physician then put additional fluid in the jada seal for a total of 300 mls in the seal/ put the jada back in [wrong technique in device usage process].Case narrative: this spontaneous report originating from united states was received from a physician, referring to a female patient of unknown age, via medical science liaison (msl), via clinical sales territory manager.The patient had pre-eclampsia, placenta accreta and other unknown comorbidities.The patient had given birth in the past.This was patient's singleton pregnancy and had vaginal delivery at the term.This was patient's second or third baby.The patient was given some medications prior to placement of the vacuum-induced hemorrhage control system (jada system).The total estimated loss of blood was 4250 ml.The patient's drug reactions or allergies and concomitant medications were not reported.This report concerns 1 patient(s) and 1 device(s).On (b)(6) 2025, the vacuum-induced hemorrhage control system (jada system) 2.0 (lot number# and expiration date was not reported) via intrauterine route inserted, by the trained physician, with 120 ml fluid in the seal.Initially, it worked.There was no device issue present, but then the patient started bleeding around the vacuum-induced hemorrhage control system (jada system) (device ineffective), so the patient was sent to interventional radiology and had a uterine artery embolization done.Physician then put additional fluid in the vacuum-induced hemorrhage control system (jada system) seal for a total of 300 ml in the seal (wrong technique in device usage process).The patient was hospitalized due to the event.The patient was not admitted in the intensive care unit, admitted only in labor and delivery.As the patient continued to bleed around the seal, so physician removed the vacuum-induced hemorrhage control system (jada system), got a bunch of clots out, and then put the vacuum-induced hemorrhage control system (jada system) back in.The ultrasound was done during the vacuum-induced hemorrhage control system (jada system) use.Patient continued to bleed and ended up with a hysterectomy.After the hysterectomy, it was found that patient was positive for an undiagnosed placenta accreta.The vacuum-induced hemorrhage control system (jada system) was removed on (b)(6) 2025.The outcome of the event device ineffective was unknown.Upon internal review, the event device ineffective was considered to be serious as required intervention (devices).When the lot number is unknown, a technical investigation of the specific manufacturing process which includes review of records associated with a known lot number cannot be performed.Medical device reporting criteria: 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.

• Brand Name: JADA SYSTEM
• Common Device Name: INTRAUTERINE VACUUM CONTRACTION SYSTEM
• Manufacturer Contact: tara brolly ; 30 hudson street; jersey city, NJ 07302
• MDR Report Key: 22410043
• Report Number: 3002806821-2025-00067
• Device Sequence Number: 9693277
• Product Code: OQY
• UDI-Device Identifier: 00840164521139
• UDI-Public: 00840164521139
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K212757
• 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): 07/07/2025

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-2002
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/07/2025
• 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: Hospitalization; Required Intervention
• Patient Sex: Female