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

Model Number JADA-1001

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

Patient Problem Vomiting (2144)

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

This initial spontaneous report originating from the united states was received from a monitor who observed a speaker program, via a company representative, referring to a female patient of unknown age.The patient's concurrent conditions, medical history and past drug reactions/allergies were not reported.No concomitant medications were reported.This report concerns 1 patient and 1 device.On an unknown date, the patient was inserted with vacuum-induced hemorrhage control system ((b)(4) system) (lot# was not reported) for an unknown indication (product used for unknown indication).On an unknown date, the patient experienced vomiting and the device moved (device dislocation).It was stated that the device was removed and replaced with bakri (required intervention).The outcome of vomiting was unknown.The causality assessment was not provided.The availability of the vacuum-induced hemorrhage control system ((b)(4) system) was unknown.Upon internal review, the event device dislocation was determined to be medically significant.Medical device reporting criteria: serious injury.Fda mdr codes: (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
• MDR Report Key: 15988486
• MDR Text Key: 305537477
• Report Number: 3017425145-2022-00150
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 00850017882003
• UDI-Public: (01)00850017882003
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: JADA-1001
• Device Catalogue Number: JADA-1001
• Date Manufacturer Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Female