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 12/01/2022

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 patient had jada placed, that she was bleeding around the jada/jada failure [device ineffective].Case narrative: this spontaneous report was received from clinical account specialist (cas) via nurse referring to a female patient of unknown age.The patient¿s historical condition, current condition, concomitant medication, and past/drug allergies were not reported.This report concerned 1 patient and 1 device.On unknown date in (b)(6) 2022, the patient started on vacuum-induced hemorrhage control system (jada system) via intrauterine route (lot# and expiry date was not reported) for hemorrhage control (hemostasis) and patient was bleeding around the vacuum-induced hemorrhage control system (jada system) (also reported as device failure) (device ineffective), so they ended up going back to the operating room to do a uterine dilation and curettage (d&c) placed a bakri.Therapy with vacuum-induced hemorrhage control system (jada system) was reported as discontinued.Upon internal review, the event ¿device ineffective¿ was determined to be serious due to 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: 16268366
• MDR Text Key: 308442492
• Report Number: 3002806821-2023-00005
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• 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: 01/30/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female