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

Model Number	2.0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The model number information was not reported or not known by the reporter.Hence, we cannot definitively determine the model with the information provided.Model 2 was selected as there is a much higher probability that this model was used as organon is currently only manufacturing/marketing this model.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
Caller reports "they do not believe it was a device failure, but the jada system did not work either, and lead to a hysterectomy [device ineffective] no other ae reported, no pqc reported.[no adverse event].Case narrative: this spontaneous report originating from united states was received from a clinical nurse leader referring to a female patient of unknown age via clinical account specialist (cas).The patient had singleton pregnancy and underwent a cesarean section for delivery.The patient's current conditions, past drug reactions/allergies and concomitant medications were not reported.This report concerns 1 patient(s) and 1 device(s).Approximately in (b)(6) 2025 (also reported as about a week ago), the healthcare professional (hcp) used a vacuum-induced hemorrhage control system (jada system) 2.0 via vaginal route (lot #, serial # and expiration date were not reported) in the late stages of post-partum hemorrhage for a patient after a failed balloon tamponade (historical device).The hcp did not believe it was a device failure, but the vacuum-induced hemorrhage control system (jada system) did not work either/ the vacuum-induced hemorrhage control system (jada system) worked without issue, but the bleeding continued and led to a hysterectomy (device ineffective).The nurse did not know if this was the total blood loss amount or the amount loss prior to vacuum-induced hemorrhage control system (jada system) use but heard 2300-3000 cc.No other adverse event (ae) reported (no adverse event)/ product quality complaint (pqc) reported.Upon internal review, the event device ineffective was determined to be serious due to 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.

• 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: 22355990
• Report Number: 3002806821-2025-00063
• Device Sequence Number: 8621536
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/30/2025

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: 2.0
• 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: 06/30/2025
• 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: Required Intervention
• Patient Sex: Female