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

Jada system did not work for cesarean section patient due to blood clots.[device ineffective] provider concerning placement of jada system seal in the vagina and not the fundus [wrong technique in device usage process] no additional ae [no adverse event] case narrative: this spontaneous report originating from united states was received from a physician via clinical educator (ce), referring to a non-pregnant female patient of unknown age.The patient¿s historical condition included singleton pregnancy, c-section, gravida iii, para 1 and delivery.The patient¿s current conditions included blood clots.The patient's concomitant medications and past drug reactions/allergies were not reported.This report concerns 1 patient(s) and 1 device(s).On an unknown date, the patient underwent an insertion procedure with vacuum-induced hemorrhage control system (jada system) via intravaginal route (lot #, serial # and expiration date were not reported) for post-partum hemorrhage.On unknown date, the vacuum-induced hemorrhage control system (jada system) did not work for cesarean section patient due to blood clots (device ineffective).Provider reported patient had to have hysterectomy.Reporter denied any quality issues with vacuum-induced hemorrhage control system (jada system).Clinical educator provided information to provider concerning placement of vacuum-induced hemorrhage control system (jada system) seal in the vagina and not the fundus (wrong technique in device usage process).The vacuum-induced hemorrhage control system (jada system) did not control bleeding and worked without issue, but the bleeding continued worked without issues, but blood clots hampered device.Patient had not used more than one vacuum-induced hemorrhage control system (jada system).This was not the operator¿s first time using or first experience with device.The patient sought medical attention.No product quality complaint (pqc) reported.No additional adverse event (ae) (no adverse event or further information reported.Therapy with vacuum-induced hemorrhage control system (jada system) was discontinued.Upon internal review, the event device ineffective was determined to be serious due to required intervention (devices).When the lot number is unknown, a technical investigation of the specific manufacturing process which includes review of records associated with a known lot number cannot be performed.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: 18998083
• MDR Text Key: 338881420
• Report Number: 3002806821-2024-00025
• 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: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• 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
• 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