MAUDE Adverse Event Report: ORGANON & CO. JADA SYSTEM; INTRAUTERINE VACUUM CONTRACTION SYSTEM

Lot Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Insufficient Information (4580)

Event Date 04/17/2024

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

A second jada was placed/ patient did have a hysterectomy and is currently in the icu not doing well [device ineffective] no additional ae reported [no adverse event] case narrative: this spontaneous report originating from united states was received from an other health professional via clinical account specialist (cas) referring to a female patient of unknown age.The patient's past medical history, current condition, concomitant medications, past drugs and past drug reactions/allergies were not reported.This report concerns 1 patient and 2 devices.On (b)(6) 2024, the patient was placed with vacuum-induced hemorrhage control system (jada system) #2 via vaginal route (lot and expiration date were not reported) for post-partum hemorrhage.A second vacuum-induced hemorrhage control system (jada system) was placed and no further clarifying information was provided on the use of the second vacuum-induced hemorrhage control system (jada system).Patient did have a hysterectomy and was currently in the intensive care unit (icu) and not doing well (device ineffective).No additional adverse event (ae) reported (no adverse event).The patient sought medical attention.The action taken of vacuum-induced hemorrhage control system (jada system) #2 was unknown.This case was linked to same patient linked case which included (event: jada was placed "somewhere at a greater than 3,000ml blood loss") (device ineffective) (reported in oars # o2404usa002811).A second jada was placed/ patient did have a hysterectomy and is currently in the icu not doing well (device ineffective) (reported in oars # o2404usa002813).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: 19172025
• MDR Text Key: 340914432
• Report Number: 3002806821-2024-00034
• 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: 04/24/2024

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?: No
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2024
• 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): Hospitalization; Required Intervention
• Patient Sex: Female