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

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

Patient Problem Disseminated Intravascular Coagulation (DIC) (1813)

Event Type  Injury  

Event Description

Dic [disseminated intravascular coagulation] utilized 2 jadas on a patient with approx.4200cc qbl where jada did not work either time/not able to control bleeding [device ineffective] case narrative: this initial spontaneous report originating from the united states, was received from a clinical educator on behalf of physician via dpoc, referring to a female patient of an unknown age.The patient's medical history, concurrent conditions, past drugs, allergies, and concomitant medications were not reported.This report concerns 1 patient and 2 devices.The physician stated that he utilized 2 vacuum-induced hemorrhage control system (jada system) (route, lot#, serial # and expiration date were not reported) for an unknown indication (product used for unknown indication) on a patient with approximately 4200 cubic centimeters (cc) quantitative blood loss (qbl) (also reported as milliliter (ml)) where vacuum-induced hemorrhage control system (jada system) did not work either time (device ineffective).In addition, it was mentioned that the patient had gone into dic (disseminated intravascular coagulation).It was reported that they were not able to control the patient¿s bleeding, hence proceeded to hysterectomy.The availability of vacuum-induced hemorrhage control system (jada system) was unknown.Patient sought medical attention.Upon internal review, the event of device ineffective were determined to be serious as it required intervention.Upon internal review, the event of disseminated intravascular coagulation was determined to be medically significant.Medical device reporting criteria: serious injury.(b)(4).

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: 16077488
• MDR Text Key: 306423386
• Report Number: 3002806821-2022-00035
• 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: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Female