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); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A 2nd system was inserted.Hcp was unable to successfully treat the patient with the 2nd system and had to perform additional interventions [device ineffective].No additional ae reported [no adverse event].Case narrative: this spontaneous report originating from united states was received from a nurse manager, on behalf of physician, referring to a female patient of unknown age, via field employee.The patient's medical history included pregnancy and delivery.The patient's concurrent conditions, 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 patient was placed with vacuum-induced hemorrhage control system (jada system) 2.0 via vaginal route (lot #, serial # and expiration date were not reported) for postpartum hemorrhage.This case was linked to same patient linked case included, on (b)(6) 2025, the healthcare professional (hcp) attempted the vacuum-induced hemorrhage control system (jada system) use, but it did not successfully treat the patient's post-partum hemorrhaging, clots were clogging the tubing, so the vacuum-induced hemorrhage control system (jada system) was removed on same day, a sweep was performed (reported in oars # (b)(4)) and a second vacuum-induced hemorrhage control system (jada system) was inserted.Hcp was unable to successfully treat the patient with the second vacuum-induced hemorrhage control system (jada system) and had to perform additional interventions (device ineffective).No additional adverse event (ae) (no adverse event) reported.No 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.
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.

• 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: 22347730
• Report Number: 3002806821-2025-00062
• Device Sequence Number: 4825406
• 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): 06/27/2025

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: 06/27/2025
• 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