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

Model Number	JADA-2002
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Lack of Effect (4065)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Ces states patient was in the or with the jada system in place for 5 hours.Provider reported patient was taken off suction and sent to the recovery room.Ces states she was in recovery for "about an hour" and began bleeding again.[device ineffective] no additional ae, no pqc reported [no adverse event].Case narrative: this spontaneous report originating from united status was received from a physician referring to a female patient of unknown age via clinical education specialist (ces).The patient was scheduled for a cesarean section however went into early labor presenting to hospital on (b)(6) 2025.The patient underwent a cesarean section and immediately after she started bleeding and her uterus was not contracting.Patient was administered all the uterotonics no specifics.The patient concurrent condition and concomitant medication was not reported.This report concerns 1 patient(s) and 1 device(s).The provider reported he felt the patient was going into dic (disseminated intravascular coagulation) initially.On (b)(6) 2025, the patient was placed with vacuum-induced hemorrhage control system (jada system) 2.0 via intrauterine route (lot, serial number and expiration date were not reported) for postpartum haemorrhage.Clinical education specialist (ces) stated patient was in the or (operating room) with the vacuum-induced hemorrhage control system (jada system) in place for 5 hours.Provider reported patient was taken off suction and sent to the recovery room.Clinical education specialist (ces) states patient was in recovery for about an hour and began bleeding again (device ineffective) (hospitalization).Patient was taken back to the or for a hysterectomy.Clinical education specialist reported the patient was intubated and in intensive care unit (icu), unknown amount of blood transfusion.Ces believes the patient lost a total of 2.5 liters of blood.No additional details regarding vacuum-induced hemorrhage control system (jada system) use were known or available at this time.No additional adverse event (no adverse event), no product quality complaint reported.The outcome of device ineffective was unknown.Upon internal review, the event device ineffective was determined to be serious due to required intervention (devices).Medical device reporting criteria: serious injury.
Additional Manufacturer Narrative
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 default text configured for block h10.
Event or Problem Description
Follow up information was received from quality investigation team on 12-jan-2026.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.
Additional Manufacturer Narrative
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 default text configured for block h10.
Event or Problem Description
This is an amendment report, the malfunction dropdown selected as yes and malfunction type selected as cirm.

• 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: 23038449
• Report Number: 3002806821-2025-00074
• Device Sequence Number: 18614399
• 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,Followup,Followup
• Report Date (Section B): 02/08/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: JADA-2002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 09/12/2025
• Supplement Report FDA Received Date: 01/19/2026; 02/08/2026
• 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; Hospitalization
• Patient Sex: Female