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

Model Number	JADA-1001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Patient have a cervical laceration [uterine cervical laceration].Case narrative: this spontaneous hearsay report originating from united states was received from a physician, referring to a female patient of unknown age via clinical account specialist (cas).The patient's medical history, concurrent conditions, 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 vacuum-induced hemorrhage control system (jada system) 1001 via vaginal route (defaulted) (lot #, serial # and expiration date were not reported) for an unknown indication.On an unknown date, the patient had a cervical laceration (uterine cervical laceration), which the healthcare provider (hcp) did not believe was present prior to vacuum-induced hemorrhage control system (jada system) placement.The physician who reported the event was not the healthcare professional of this device but heard about the event secondhand.No product could be obtained.The outcome of the event uterine cervical laceration was unknown.The reporter¿s causality assessment was not reported.Follow-up information has been received from physician on 31-jan-2025.The patient had a vaginal delivery, coded during delivery.The patient's past medications included methylergometrine maleate (methergine), tranexamic acid (txa) and misoprostol (cytotec).The patient was placed with vacuum-induced hemorrhage control system (jada system) for hemorrhaging.The patient had a hysterectomy as a result of hemorrhaging and required intensive care unit (icu) admission.Upon internal review, the event uterine cervical laceration was considered as serious due to required intervention.Medical device reporting criteria: serious injury.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.

• 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: 21321125
• Report Number: 3002806821-2025-00005
• Device Sequence Number: 7915111
• Product Code: OQY
• UDI-Device Identifier: 00850017882003
• UDI-Public: 00850017882003
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201199
• 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
• Report Date (Section B): 02/06/2025

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-1001
• 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
• Initial Report FDA Received Date: 02/06/2025
• 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; Hospitalization
• Patient Sex: Female