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); Organ Dehiscence (2502); 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.It appears that jada suction was achieved indicating device is functioning.In reference to jada causing the uterine dehiscence, we will need more information to deduce this claim.Do we have clinical data to support that jada suction can cause this event? however, there is report detailing that blood was able to be evacuated through the jada device to verify if jada was inserted and functioned correctly.
Event or Problem Description
Patient treated with jada but failed and patient have to go for hysterectomy "[device ineffective]" , dr think it failed possibly due to her previous scar was very thin and maybe because of suction of jada causing it to dehisce "[uterine dehiscence]" , dr think it failed possibly due to her previous scar was very thin and maybe because of suction of jada causing it to dehisce "[injury associated with device]".Case narrative: this spontaneous report originating from malaysia was received from physician referring to a female patient of unknown age via designated point of contact and company representative.The patient had history of scar which was very thin.The patient's current condition, drug reactions or allergies and concomitant medications were not reported.This report concerns 1 patient (s) and 1 device (s).On an unknown date, the patient was placed with the vacuum-induced hemorrhage control system (jada system) 2002 via vaginal route (defaulted), (lot/batch# number and expiration date were not reported) for an unknown indication.On an unknown date, the patient treated with vacuum-induced hemorrhage control system (jada system) but failed and patient have to go for hysterectomy (device ineffective).The physician thought it failed possibly due to her previous scar being very thin and might be because of suction of vacuum-induced hemorrhage control system (jada system) causing it to dehisce (uterine dehiscence, injury associated with device).The outcome of event uterine dehiscence was unknown.The reporter considered the event uterine dehiscence to be related with vacuum-induced hemorrhage control system (jada system).Upon internal review, the event device ineffective was determined to be serious due to required intervention (devices).Upon internal review, the event uterine dehiscence was determined 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.
Event or Problem Description
Patient treated with jada but failed and patient have to go for hysterectomy "[device ineffective]", dr think it failed possibly due to her previous scar was very thin and maybe because of suction of jada causing it to dehisce "[uterine dehiscence]" , dr think it failed possibly due to her previous scar was very thin and maybe because of suction of jada causing it to dehisce "[injury associated with device]".Case narrative: this spontaneous report originating from malaysia was received from physician referring to a female patient of unknown age via designated point of contact and company representative.The patient had history of scar which was very thin.The patient's current condition, drug reactions or allergies and concomitant medications were not reported.This report concerns 1 patient (s) and 1 device (s).On an unknown date, the patient was placed with the vacuum-induced hemorrhage control system (jada system) 2002 via vaginal route (defaulted), (lot/batch# number and expiration date were not reported) for an unknown indication.On an unknown date, the patient treated with vacuum-induced hemorrhage control system (jada system) but failed and patient have to go for hysterectomy (device ineffective).The physician thought it failed possibly due to her previous scar being very thin and might be because of suction of vacuum-induced hemorrhage control system (jada system) causing it to dehisce (uterine dehiscence, injury associated with device).The outcome of event uterine dehiscence was unknown.The reporter considered the event uterine dehiscence to be related with vacuum-induced hemorrhage control system (jada system).Upon internal review, the event device ineffective was determined to be serious due to required intervention (devices).Upon internal review, the event uterine dehiscence was determined 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.This is an amended report.Incident severity was updated from no incident to incident.
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.It appears that jada suction was achieved indicating device is functioning.In reference to jada causing the uterine dehiscence, we will need more information to deduce this claim.Do we have clinical data to support that jada suction can cause this event? however, there is report detailing that blood was able to be evacuated through the jada device to verify if jada was inserted and functioned correctly.
Event or Problem Description
Follow up information was received on 26-jun-2025.No new follow up information is expected and the report is considered as final.
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.It appears that jada suction was achieved indicating device is functioning.In reference to jada causing the uterine dehiscence, we will need more information to deduce this claim.Do we have clinical data to support that jada suction can cause this event? however, there is report detailing that blood was able to be evacuated through the jada device to verify if jada was inserted and functioned correctly.No new follow up information is expected and the report is considered as final.This is default text configured for block h10.

• 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: 22393016
• Report Number: 3002806821-2025-00065
• Device Sequence Number: 15718470
• Product Code: OQY
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K212757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2026

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; 08/26/2026
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 07/04/2025; 09/09/2026
• 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: Other; Required Intervention
• Patient Sex: Female