MAUDE Adverse Event Report: ORGANON LLC 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); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The green part that goes into the patient's cervix was getting clogged with clots [device occlusion].The jada worked without issue, but the bleeding continued [device ineffective].No additional aes reported [no adverse event].Case narrative: this spontaneous report originating from united states was received from the office manager referring to a 37-year-old female patient.The patient's obstetric history included multigravida (gravida 3) and multiparous (para 2).The patient's medical history included delivery and pregnancy (singleton).The patient's past drug reactions/allergies and concomitant medications were not reported.This report concerns 1 patient(s) and 1 device(s).On (b)(6) 2025, the patient was placed with vacuum-induced hemorrhage control system (jada system) via transvaginal route (lot #, serial # and expiration date were not reported) for postpartum hemorrhage.The green part that went into the patient's cervix was getting clogged with clots (device occlusion) and had to use second vacuum-induced hemorrhage control system (jada system) because of the clots and the clogging (device ineffective).The patient was hospitalized approximately in (b)(6) 2025.The second vacuum-induced hemorrhage control system (jada system) stopped the bleeding.No additional interventions were needed after vacuum-induced hemorrhage control system (jada system) to control the abnormal postpartum uterine bleeding or hemorrhage.The device was discarded.No additional adverse events (aes) reported (no adverse event).No product quality complaints (pqcs) reported.The reporter considered the device occlusion and device ineffective was serious due to life threatening.Upon internal review, the events device occlusion and device ineffective was determined to be serious due to required intervention (devices).Medical device reporting criteria: serious injury.This is one of several reports received from the same reporter.
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.
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.The device is assembled per specifications where in-process and final inspections are conducted by trained personnel.No outcome from the investigation could be determined since no complaint sample or lot identification has been provided.If the complaint sample or lot number become available, this complaint will be re-opened and additional investigation may be performed.This is default text configured for block h10.
Event or Problem Description
Follow up report received on 04-dec-2025.This is a final report.Manufacturing statement: no complaint sample or device lot number are available for evaluation, therefore an unknown investigation was performed.The device is assembled per specifications where in-process and final inspections are conducted by trained personnel.No outcome from the investigation could be determined since no complaint sample or lot identification has been provided.If the complaint sample or lot number become available, this complaint will be re-opened and additional investigation may be performed.This is one of several reports received from the same reporter.

• Brand Name: JADA SYSTEM
• Common Device Name: INTRAUTERINE VACUUM CONTRACTION SYSTEM
• Manufacturer (Section D): ORGANON LLC; 30 hudson street; jersey city NJ 07302
• Manufacturer (Section G): ORGANON LLC; 30 hudson street; jersey city NJ 07302
• Manufacturer Contact: tara brolly ; 30 hudson street; jersey city, NJ 07302
• MDR Report Key: 23199573
• Report Number: 3002806821-2025-00078
• Device Sequence Number: 9433883
• 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: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: JADA-2002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/02/2025
• Supplement Report FDA Received Date: 12/09/2025
• 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: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female