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 Date 01/01/2023

Event Type  Injury  

Event Description

It was expelled with the seal inflated [device expulsion].Case narrative: this spontaneous report originating from the united states, was received from a medical science liaison (msl) reporting on behalf of a nurse via, referring to a non pregnant female patient of unknown age.The patient's concurrent condition included hospitalization.The patient's historical conditions included delivery and multiple pregnancies.Her historical drug included carboprost trometamol (hemabate) and other unknown uterotonics.Her concomitant medications and allergies were not reported.This report concerns 1 patient and 1 device.On an unknown date in 2023 (reported as a while ago) after delivery, the patient was inserted with vacuum-induced hemorrhage control system (jada system) via vaginal route (lot # and expiry date was not reported) for an unknown indication (product used for unknown indication).For this delivery had received carboprost trometamol (hemabate) and other unknown uterotonics.It was reported few minutes after it was in, it was expelled with the seal inflated (device expulsion).This resulted in prolongation of hospitalization.Nurse did not report any damage or breakage to the vacuum-induced hemorrhage control system (jada system).Nurse did not had other patient information or details about event.The availability of vacuum-induced hemorrhage control system (jada system) was unknown.Upon internal review the event of device expulsion was considered to be medically significant.Medical device reporting criteria: serious injury."fda code: (health effects - health impact per annex f): 4607 hospitalization or prolonged hospitalization(the patient¿s hospitalization was prolonged due to the events).Fda code: (health effects - health impact per annex f): 4648 insufficient information (there is not yet enough information available to classify the health impact).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.

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: 16700277
• MDR Text Key: 312861596
• Report Number: 3002806821-2023-00034
• 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: Other
• Type of Report: Initial
• Report Date: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/07/2023
• 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; Hospitalization
• Patient Sex: Female