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 Insufficient Information (4580)

Event Type  Injury  

Event Description

Jada device did not stop control the bleeding [device ineffective].The event (specifics of event unknown by reporter) was above what jada could have provided [adverse event].Case narrative: this initial spontaneous report originating from the united states, was received from clinical educator (ce) (company representative) who had received information from a physician referring to a female patient of unknown age.The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported.This report concerned 1 patient and 1 device.On an unknown date, the patient was inserted with vacuum-induced hemorrhage control system (jada system) via unknown route (lot# and expiry date were not reported) for unknown indication (product used for unknown indication) by attending physician.The provider felt comfortable using the vacuum-induced hemorrhage control system (jada system), but the event (specifics of event unknown by reporter) was above what vacuum-induced hemorrhage control system (jada system) could provide (adverse event).The patient "needed transfusion but they did not keep platelets on hand¿.The vacuum-induced hemorrhage control system (jada system) device did not stop control the bleeding (device ineffective).The patient ended up having a hysterectomy.The provider reported that they used the vacuum-induced hemorrhage control system (jada system) early in the algorithm and was no fault of the vacuum-induced hemorrhage control system (jada system).The ce did not have any further information available.The patient sought for medical attention.Therapy with the vacuum-induced hemorrhage control system (jada system) was discontinued.Upon internal review, the events of device ineffective were determined to be serious due to required intervention.Medical device: serious injury.Fda code: (health effects - health impact per annex f): 4624 surgical intervention (one or more surgical procedures was required, or an existing procedure changed).Fda code: (health effects - health impact per annex f): 4643 patient required an infusion of whole blood or a blood component directly into the bloodstream.

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: 16436082
• MDR Text Key: 310152075
• Report Number: 3002806821-2023-00018
• 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: 02/24/2023

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?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/24/2023
• 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): Required Intervention
• Patient Sex: Female