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	Rupture (2208)
Date of Event	01/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Posterior uterine rupture [uterine rupture].Case narrative: this spontaneous report originating from united states was received from other health professional (risk manager) referring to a 35-year-old female patient via food and drug administration (fda).The patient had cesarean section delivery.The patient's concurrent condition included hypotension.The patient¿s concomitant medications and past drug reactions/allergies were not reported.This report concerns 1 patient(s) and 1 device(s).On (b)(6) 2022, the patient was placed with vacuum-induced hemorrhage control system (jada system) 1.0 via intravaginal route (defaulted) (lot #, serial # and expiration date were not reported) for post-partum hemorrhage.On (b)(6) 2022, the vacuum-induced hemorrhage control system (jada system) placed, and the patient stabilized.Patient transferred to surgical intensive unit (sicu) subsequently with need for return to surgery.The patient with a supracervical hysterectomy after finding posterior uterine rupture (uterine rupture).It was unsure if vacuum-induced hemorrhage control system (jada system) involved in complication.Event caused prolonged hospitalization.The outcome of event uterine rupture was unknown.The reporter's causality assessment was not reported.Upon internal review, the event uterine rupture was determined to be medically significant and 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
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: 21641332
• Report Number: 3002806821-2025-00050
• Device Sequence Number: 18081776
• 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
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/19/2025

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2025
• 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; Other; Hospitalization
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 119 KG