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 Uterine Perforation (2121)

Event Date 01/01/2023

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

In the operating room, patients abdomen was opened up and jada found to be protruding through the uterus [uterine rupture].In the operating room, patients abdomen was opened up and jada found to be protruding through the uterus [device dislocation].Jada placed in patient, patient still bleeding [device ineffective].Case narrative: this spontaneous report originating from the united states was received from a registered nurse via clinical sales educator (cse) and designated point of contact (dpoc), referring to a female patient of an unknown age.The patient's historical conditions included pregnancy, cesarean section, vaginal delivery after cesarean section and cervical laceration which was repaired.Her current condition was considered as hospitalization.Her past drugs/ allergies and concomitant medications were not reported.This report concerns 1 patient and 1 device.Approximately on an unknown date in 2023 (reported as "few months ago"), the patient was placed with vacuum-induced hemorrhage control system (jada system) via vaginal route for post-partum hemorrhage after delivery, however, the patient was still bleeding (device ineffective).In the operating room (or), patient's abdomen was opened up and vacuum-induced hemorrhage control system (jada system) was found to be protruding through the uterus (uterine rupture and device dislocation).Reportedly, the patient was sent to intensive care unit (icu) (considered as hospitalization prolonged).Reportedly, the patient sought medical attention and received treatment.It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.For vacuum-induced hemorrhage control system (jada system), lot number and serial number were not provided.Upon internal review, the events of uterine rupture and device dislocation were considered to be serious due to the seriousness criteria of medically significant and required intervention.The event device ineffective was considered as serious due to 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).Fda code: (health effects - health impact per annex f): 4607 hospitalization or prolonged hospitalization (hospitalization or prolonged hospitalization due to the health damage accompanying the use of device).

• 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: 17744017
• MDR Text Key: 323380947
• Report Number: 3002806821-2023-00109
• 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: Other
• Type of Report: Initial
• Report Date: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: 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): Hospitalization; Required Intervention; Other
• Patient Sex: Female