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 04/19/2023

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

It did not control her bleeding [device ineffective], patient also diagnosed with dic and had to be admitted to the icu.[disseminated intravascular coagulation].Case narrative: this initial spontaneous report originating from the united states, was received from a physician via field employee referring to a non-pregnant female patient.The patient's concurrent condition included hospitalization and historical condition included vaginal delivery.Her concomitant medication included unspecified uterotonics.This report concerned 1 patient and 1 device.On (b)(6)2023, the patient underwent vacuum-induced hemorrhage control system (jada system) via vaginal route as directed (lot# and expiry date were not reported) placement, by the provider for postpartum hemorrhage.However, it did not control her bleeding (device ineffective).Uterotonics (unspecified) were given but reporter did not know if they were given prior to the vacuum-induced hemorrhage control system (jada system).Blood products required during peripartum period.The provider reported 3 liters of blood were lost.The patient sought medical attention.The vacuum-induced hemorrhage control system (jada system) was removed on the same day.The patient had to be taken to the (or) and had to have a hysterectomy.The patient also diagnosed with disseminated intravascular coagulation (dic) and had to be admitted to the intensive care unit (icu) (hospitalization prolonged).The availability of vacuum-induced hemorrhage control system (jada system) was unknown.Upon internal review, the event of device ineffective was determined to be serious as it required intervention.Upon internal review, the event 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): 4624 surgical intervention (one or more surgical procedures was required, or an existing procedure changed).

• 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: 16902045
• MDR Text Key: 314904870
• Report Number: 3002806821-2023-00052
• 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: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• 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): Other; Required Intervention; Hospitalization
• Patient Sex: Female