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	Disseminated Intravascular Coagulation (DIC) (1813); Hemorrhage/Blood Loss/Bleeding (1888); Insufficient Information (4580)
Date of Event	01/01/2026
Type of Reportable Event	Death
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.This is default text configured for block h10.
Event or Problem Description
The patient ultimately required a hysterectomy due to excessive vaginal bleeding, subsequently developed dic, and, unfortunately, did not survive.[disseminated intravascular coagulation] , had worsening medical condition [condition aggravated] , the patient ultimately required a hysterectomy due to excessive vaginal bleeding, subsequently developed dic, and, unfortunately, did not survive.[device ineffective] , md placed jada on a patient 7 weeks postpartum.[device use issue].Case narrative: this spontaneous report originating from united states was received from a consumer referring to a female patient of unknown age.The patient concurrent condition, concomitant medication, past drug/allergy was not reported.This report concerns 1 patient(s) and 1 device(s).On an unknown date in 2026, the patient's menses had returned, and the bleeding became extremely heavy and patient needed a dilation and curettage (d&c) (historical condition).Two hours post d&c, the patient experienced heavy vaginal bleeding and the doctor had placed the vacuum-induced hemorrhage control system (jada system) on a 7 week postpartum haemorrhage patient (device use issue) via vaginal route (strength, dose, frequency, lot number and expiration date were not reported).Patient did well and had no complaints.Later on, hospital had informed that the patient ultimately required a hysterectomy due to excessive vaginal bleeding (device ineffective), subsequently developed disseminated intravascular coagulation (dic), had worsening medical condition (condition aggravated), and ended up passing away due to unknown cause of death.It was unknown if autopsy was performed or not.The reporter causality assessment was not reported.Upon internal review, the events disseminated intravascular coagulation, condition aggravated were determined to be medically significant.Upon internal review, the event device ineffective was determined to be serious due to required intervention (devices).Case comments: based on the clinically relevant information currently available for this individual case and the fda decision tree, the case was considered reportable, since the causal role of the device in the patient¿s deterioration and death could not be ruled out.
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.This is default text configured for block h10.
Event or Problem Description
Follow up information received on 21-apr-2026.This is final report.Component code included from international medical device regulators forum website "annexes a-g: imdrf terminologies for categorized adverse event reporting (aer) - medical device problem device code value.Insufficient component information [g07003]: there is not yet enough information available to classify the medical device component.A complaint sample was not available for evaluation, therefore the complaint could not be substantiated.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 a complaint sample has not been provided.If the complaint sample becomes available, this complaint will be re-opened and additional investigation may be performed.
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.This is default text configured for block h10.
Event or Problem Description
This is an amendment report, f02 imdrf code has been added.

• 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: 24680972
• Report Number: 3002806821-2026-00005
• Device Sequence Number: 9652786
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/15/2026

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
• Device Lot Number: UNKNOWN
• 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; Not provided
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 04/24/2026; 05/15/2026
• 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; Death; Other
• Patient Sex: Female