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	Wound Dehiscence (1154); Hemorrhage/Blood Loss/Bleeding (1888); Insufficient Information (4580)
Date of Event	01/01/2025
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
The jada and it wasn't working to control the patient's bleeding [device ineffective] there was a dehiscence of the patient's incision, which they believed could have been caused from either the jada device or vigorous fundal rubbing.[uterine dehiscence] they believed could have been caused from either the jada device or vigorous fundal rubbing.[injury associated with device] case narrative: this spontaneous report originating from united states was received from a physician referring to a female patient of unknown age via clinical account specialist (cas).Approximately on an unknown date in 2025 (also reported as sometime a couple weeks), the patient had c-section.She started bleeding in the recovery room.The patient received oxytocin (pitocin) and methylergometrine maleate (methergine) (at an unknown time during this event).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).Approximately on an unknown date in 2025 (also reported as sometime a couple weeks ago) (discrepant information, as also reported as sometime two weeks ago), 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 hemorrhaging.The vacuum-induced hemorrhage control system (jada system) wasn't working to control the patient's bleeding (device ineffective), so they took the patient back to the operation room (or) and re-opened her up to stop the bleeding.There was a dehiscence of the patient's incision, which they believed could have been caused from either the vacuum-induced hemorrhage control system (jada system) device or vigorous fundal rubbing (uterine dehiscence) (injury associated with device).The patient lost an estimated 6 liters of blood and got countless units transfused back into her.The patient did not end up having to get a hysterectomy.It was unknown the present status of the patient.The inserting health care professional (hcp) was unknown.The outcome of device ineffective, injury associated with device and uterine dehiscence was unknown.The reporter considered injury associated with device and uterine dehiscence to be related to vacuum-induced hemorrhage control system (jada system).Upon internal review, the event device ineffective and uterine dehiscence was determined to be medically significant.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.
Event or Problem Description
The jada and it wasn't working to control the patient's bleeding [device ineffective] there was a dehiscence of the patient's incision, which they believed could have been caused from either the jada device or vigorous fundal rubbing.[uterine dehiscence] they believed could have been caused from either the jada device or vigorous fundal rubbing.[injury associated with device] case narrative: this spontaneous report originating from united states was received from a physician referring to a female patient of unknown age via clinical account specialist (cas).Approximately on an unknown date in 2025 (also reported as sometime a couple weeks), the patient had c-section.She started bleeding in the recovery room.The patient received oxytocin (pitocin) and methylergometrine maleate (methergine) (at an unknown time during this event).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).Approximately on an unknown date in 2025 (also reported as sometime a couple weeks ago) (discrepant information, as also reported as sometime two weeks ago), 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 hemorrhaging.The vacuum-induced hemorrhage control system (jada system) wasn't working to control the patient's bleeding (device ineffective), so they took the patient back to the operation room (or) and re-opened her up to stop the bleeding.There was a dehiscence of the patient's incision, which they believed could have been caused from either the vacuum-induced hemorrhage control system (jada system) device or vigorous fundal rubbing (uterine dehiscence) (injury associated with device).This is an amended report.Incident severity was updated from no incident to incident.The patient lost an estimated 6 liters of blood and got countless units transfused back into her.The patient did not end up having to get a hysterectomy.It was unknown the present status of the patient.The inserting health care professional (hcp) was unknown.The outcome of device ineffective, injury associated with device and uterine dehiscence was unknown.The reporter considered injury associated with device and uterine dehiscence to be related to vacuum-induced hemorrhage control system (jada system).Upon internal review, the event device ineffective and uterine dehiscence was determined to be medically significant.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 (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: 22372952
• Report Number: 3002806821-2025-00064
• Device Sequence Number: 7918847
• 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
• Report Date (Section B): 07/04/2025

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
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 07/04/2025
• 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: Other
• Patient Sex: Female