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 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

Hysterectomy with extensive blood loss [device ineffective].Case narrative: this initial spontaneous report originating from the united states, was received from a physician referring to a non-pregnant 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) (1 device) via vaginal route (lot #, serial #, and expiry date were not reported) for postpartum hemorrhage by a health care professional (unspecified) at an unknown facility.However, the patient was transferred to the reporting facility for hysterectomy with extensive blood loss (device ineffective, onset date: unknown).The estimated blood loss (ebl/qbl) prior to vacuum-induced hemorrhage control system (jada system) use was 3000 cubic centimeter (cc).The physician was unsure if there was a malfunction of vacuum-induced hemorrhage control system (jada system).The patient sought medical attention.The availability of vacuum-induced hemorrhage control system (jada system) was unknown.Upon internal review, the event of device ineffective was determined to be serious as it required intervention.Medical device reporting criteria: serious injury.Fda code: (health effects health impact per annex f): 4648 insufficient information (there is not yet enough information available to classify the health impact).Fda code: (health effects health impact per annex f): 4624 (one or more surgical procedures was required, or an existing procedure changed).

• 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: 16435040
• MDR Text Key: 310138310
• Report Number: 3002806821-2023-00016
• 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: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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