MAUDE Adverse Event Report: ORGANON & CO. JADA SYSTEM; INTRAUTERINE VACUUM CONTRACTION SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Thrombosis/Thrombus (4440)

Event Date 09/20/2023

Event Type  Injury  

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 Description

She continued to have clots [thrombosis].The patient continued to bleed vaginally [device ineffective].Case narrative: this spontaneous report originating from the united states was received from a physician via clinical account specialist (cas), referring to a female patient of an unknown age.The patient's historical conditions included pregnancy and vaginal delivery and had lost about 2000 cc of blood prior to vacuum-induced hemorrhage control system (jada system) placement.Her current conditions, past drugs/ allergies and concomitant medications were not reported.This report concerns 1 patient and 1 device.Approximately on (b)(6) 2023, the patient was placed with vacuum-induced hemorrhage control system (jada system) via intrauterine route for postpartum hemorrhage by the physician.The provider reported that she had put 60 ml of fluid in the cervical seal, but the patient continued to bleed vaginally (device ineffective).After "she continued to had clots" (thrombosis), patient was taken to the operating room (or) for a dilation and curettage (d&c).She stabilized in the or and was still in the hospital as of (b)(6) 2023 (hospitalization prolonged due to the events).Cas had no additional information.It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.For vacuum-induced hemorrhage control system (jada system), lot number and serial number were not provided.The outcome of thrombosis was not reported.The causality assessment was not provided.Upon internal review, the event of thrombosis was determined to be medically significant, and the events of thrombosis and device ineffective were 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.Fda code: (health effects - health impact per annex f): 4607 hospitalization or prolonged hospitalization (hospitalization or prolonged hospitalization due to the health damage accompanying the use of device).Fda code: (health effects - health impact per annex f): 4624 surgical intervention (one or more surgical procedures was required, or an existing procedure changed).

• Brand Name: JADA SYSTEM
• Type of Device: INTRAUTERINE VACUUM CONTRACTION SYSTEM
• Manufacturer (Section D): ORGANON & CO.; 30 hudson street; jersey city NJ 07302
• Manufacturer (Section G): ORGANON & CO.; 30 hudson street; jersey city NJ 07302
• Manufacturer Contact: 30 hudson street; jersey city, NJ 07302
• MDR Report Key: 17816101
• MDR Text Key: 324218095
• Report Number: 3002806821-2023-00116
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 510K K201199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Sex: Female