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

As a result, the jada system did not work properly.The patient continued bleeding and had to undergo a hysterectomy [device ineffective].Provider admitted that provider did not know how to use the jada system.Caller states that provider filled fluid into the wrong chamber [wrong technique in device usage process].Case narrative: this spontaneous report was received from a physician via company representative referring to a female patient of unknown age.The patient gave birth at 34 weeks gestation and had pre-eclampsia.The patient's concurrent conditions included uterine atony.The patient's concomitant medications, and drug reactions/allergies were not reported.This report concerns 1 patient and 1 device.On an unknown date in 2022 (reported as "a few months ago"), the patient was started on vacuum-induced hemorrhage control system (jada system) via an unknown route for abnormal postpartum bleeding (postpartum bleeding) (lot# and expiration date were not reported).It was reported that the physician (also reported as "provider") admitted that the physician did not know how to use the vacuum-induced hemorrhage control system (jada system).On an unknown date in 2022 (reported as "a few months ago"), the physician "filled fluid into the wrong chamber" (wrong technique in device usage process).As a result, the vacuum-induced hemorrhage control system (jada system) did not work properly.The patient continued bleeding and had to undergo a hysterectomy (device ineffective).It was also reported that the patient did not die.No additional adverse event (ae) or product quality complaint (pqc) were identified.No additional information was known at the time of reporting.The availability of vacuum-induced hemorrhage control system (jada system) was unknown.For vacuum-induced hemorrhage control system (jada system), lot number and serial number were not available.Upon internal review, the event of "device ineffective" was determined to be serious as it required intervention.Medical device reporting criteria: serious injury.

• 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: 15853499
• MDR Text Key: 304205221
• Report Number: 3002806821-2022-00008
• 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: 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
• Device Operator: Health Professional
• 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): Required Intervention
• Patient Sex: Female