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 Disseminated Intravascular Coagulation (DIC) (1813)

Event Date 04/20/2023

Event Type  Injury  

Event Description

Disseminated intravascular coagulation (dic) [disseminated intravascular coagulation].Case narrative: this spontaneous report originating from united states was received from a physician referring to a patient of unknown age and gender.The patient's concurrent conditions, concomitant medications, medical history, and past drug reactions/allergies were not reported.On (b)(6) 2023 (also reported as "currently"), the patient was inserted with vacuum-induced hemorrhage control system (jada system) by attending physician for an unknown indication.On the same day, the patient was diagnosed with disseminated intravascular coagulation (dic).The reporter stated they did not know if they should keep the device in place or remove it.Physician was currently treating the patient.The patient sought medical attention.No additional adverse event (ae), no product quality complaint (pqc) reported.The vacuum-induced hemorrhage control system (jada system) was not available for evaluation.For vacuum-induced hemorrhage control system (jada system) lot number and serial number were not provided.Therapy with vacuum-induced hemorrhage control system (jada system) was continued.Outcome of event disseminated intravascular coagulation was reported as not recovered.The reporter's causality assessment was not provided.Upon internal review, the event of disseminated intravascular coagulation was determined to be medically significant.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.Fda code: (health effects - health impact per annex f): 4641 unexpected medical intervention (patient required an unforeseen medical intervention, excluding surgery, which was not on the original treatment plan.).

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: 16860154
• MDR Text Key: 314456128
• Report Number: 3002806821-2023-00045
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• 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): Other