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); Insufficient Information (4580)

Event Type  Injury  

Event Description

Jada device stop control the bleeding?no [device ineffective].Patient was only 1-2 cm dilated vaginally which reported states was off label use [contraindicated device used].Case narrative: this initial spontaneous report originating from the united states, was received from a physician via field employee referring to a non-pregnant female patient of unknown age.The patient's concurrent conditions included hospitalization.The patient's historical conditions included pregnancy and cesarean delivery.Concomitant medications were not reported.It was reported that the patient did not start hemorrhaging till 7 hours post-delivery.This report concerns 1 patient and 1 device.On an unknown date, physician attempted to place vacuum-induced hemorrhage control system (jada system) via vaginal route (lot# and expiration date were not reported) for postpartum hemorrhage.The patient was only 1-2 centimeters (cm) dilated vaginally which reported stated as off label use (contraindicated device used).It was reported that the vacuum-induced hemorrhage control system (jada system) did not control the bleeding (device ineffective).Patient lost approximately 5000 cubic centimeters (cc) of blood and had to be mass transfused.It was reported that the event caused prolonged hospitalization.The patient underwent blood transfusion.Patient did not had hysterectomy.The therapy with vacuum-induced hemorrhage control system (jada system) was discontinued.The availability of vacuum-induced hemorrhage control system (jada system) was unknown.No additional adverse event (ae) or product quality complaint (pqc) reported.Upon internal review, the event of device ineffective was determined to be serious as it required intervention.Medical device reporting criteria: serious injury: fda code: (health effects-health impact per annex f): 4643 blood transfusion (patient required an infusion of whole blood or a blood component directly into the bloodstream).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).

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
• 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: 16610242
• MDR Text Key: 311959846
• Report Number: 3002806821-2023-00028
• 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: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/24/2023
• 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
• Patient Sex: Female