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

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

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Failed case with use of jada [device ineffective].Case narrative: this initial spontaneous report originating from (b)(6), was received from a physician (also reported as healthcare professional) via company representative, referring to a patient of unknown age and gender.The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions/allergies were not reported.This report concerns 1 patient and 1 device.On an unknown date, the patient underwent vacuum-induced hemorrhage control system (jada system) placement via an unknown route for an unknown indication (lot # and expiration date were not reported).A failed case with use of vacuum-induced hemorrhage control system (jada system) was reported (device ineffective, onset date: unknown).It was reported that only 60 milliliter (ml) of fluid was used in the cervical seal.No additional details were provided.No additional adverse event (ae) and no product quality complaint (pqc) were identified.It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.Upon internal review, the event of device ineffective was determined to be medically significant.Medical device reporting criteria: serious 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.

• 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: 16077407
• MDR Text Key: 306418151
• Report Number: 3002806821-2022-00034
• 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: Physician
• Type of Report: Initial
• Report Date: 12/30/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2022
• 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): Other