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 Date 01/01/2022

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

The jada system was not successful at controlling the bleeding / did the jada device stop control the bleeding? no [device ineffective].Case narrative: this initial spontaneous report originating from united states was received from a nurse via clinical educator referring to a female patient of unknown age.The patient's historical condition included pregnancy (discrepant information provided: "it was reported that the patient was currently pregnant").The patient's concomitant medications, and drug reactions/allergies were not reported.This report concerns 1 patient and 1 device.Approximately on an unknown date in 2022 (reported as within the last six weeks), the patient underwent vacuum-induced hemorrhage control system (jada system) placement for abnormal postpartum uterine bleeding or hemorrhage (postpartum haemorrhage) (lot# was not reported).It was reported that vacuum-induced hemorrhage control system (jada system) came in a blue seal valve, kit and green carton.It was reported that vacuum-induced hemorrhage control system (jada system) was not successful at controlling the bleeding (device ineffective) (required intervention) and had to be discontinued.The patient had a bakri placed after the removal of the vacuum-induced hemorrhage control system (jada system).The nurse manager stated that she believed the problem was provider education issues.It was reported that not more than one vacuum-induced hemorrhage control system (jada system) was used.It was reported that patient had sought medical attention and was already in health care provider (hcp) facility.No other symptoms were reported for the patient.No additional information was provided.It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.Upon internal review, the event device ineffective was considered to be medically significant.This is one of 2 reports received from the same reporter.Medical device reporting criteria: serious injury.Fda code: (health effects - health impact per annex f): 4641 unexpected medical intervention (patient required an unforeseen medical intervention, excluding surgery, which was not on the original treatment plan).

• 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: 15853528
• MDR Text Key: 304205576
• Report Number: 3002806821-2022-00010
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/23/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/23/2022
• 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