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 Date 12/27/2022

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

I placed a jada system but bleeding was still occurring/ did the jada device stop control the bleeding? no [device ineffective].Case narrative: this spontaneous report was received from a physician referring to a female patient of unknown age.The patient's medical history included pregnancy, caesarean section (c-section).The patient's concomitant medications, and drug reactions/allergies were not reported.This report concerns 1 patient and 1 device.The physician reported that on (b)(6) 2022 the patient had postpartum bleeding after a c-section.There was no bleeding at all in the abdomen however, vaginal bleeding started an hour after the c-section.The physician placed a vacuum-induced hemorrhage control system (jada system) via vaginally (lot# and expiration date were not reported) for postpartum bleeding (postpartum haemorrhage) but bleeding was still occurring (device ineffective).It was reported that the vacuum-induced hemorrhage control system (jada system) was not removed and was not reinserted for any reason.The patient had sought medical attention and treatment was given.The patient was currently in interventional radiology.The physician reported that they were trying to localize the vascular source of bleeding and perform an arterial embolization.The physician wanted to know if the vacuum-induced hemorrhage control system (jada system) should be kept in place after the embolization was completed.No additional information was provided at the time of reporting.It was reported that vacuum-induced hemorrhage control system (jada system) was still in place in patient at the time of reporting.Upon internal review, the event of device ineffective was determined to be serious as it required intervention.Medical device reporting criteria: serious injury.(b)(4).

• 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: 16082662
• MDR Text Key: 306499947
• Report Number: 3002806821-2023-00001
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/02/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/02/2023
• 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