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

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

Patient Problems Hemorrhage/Bleeding (1888); Insufficient Information (4580)

Event Date 12/01/2023

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

A large laceration was discovered on the posterior lower uterine segment of uterus [uterine injury] patient's abdomen was opened, and a large hematoma was discovered to be surrounding the right ovary which could not be dissected away [ovarian haematoma] bleeding could not be controlled/the laceration may have been caused by jada [device ineffective] insertion was difficult [device difficult to use] case narrative: this spontaneous report originating from united states was received from a nurse manager via clinical educator (ce), referring to a female patient of unknown age.The patient's medical history included c-section and pregnancy.The patient¿s drug reactions/allergies, concurrent conditions and concomitant therapies were not reported.This report concerns 1 patient(s) and 1 device(s).On an unknown date, the patients were inserted with vacuum-induced hemorrhage control system (jada system) via vaginal route, (dose, frequency and lot, expiry date was not reported) for post-partum hemorrhage.On an unknown date in december, the patient with failure to progress had an uncomplicated c-section (primary c-section patient).Patient was sent to post anesthesia care unit (pacu) and about 15-20 minutes later, began experiencing post-partum hemorrhage which was suspected to be atony related.Vacuum-induced hemorrhage control system (jada system) was placed with no instrumentation, but bleeding could not be controlled (device ineffective).Patient continued to bleed around the cervical seal.Reporter mentioned that the customer stated it was difficult to place due to the volume of blood (device difficult to use).Patient was taken to the operation room for a dilatation and curettage.Reporter was seeking clarification as she was unsure if vacuum-induced hemorrhage control system (jada system) was placed before or after the dilatation and curettage.Patient's abdomen was opened, and a large hematoma was discovered to be surrounding the right ovary which could not be dissected away (ovarian haematoma), so the provider did a right oophorectomy.A large laceration was discovered on the posterior lower uterine segment of uterus (uterine injury).Provider stated when hysterotomy was closed, laceration was not present.Patient was admitted to the intensive care unit and since recovered and been discharged.Reporter clarified that although the email said "perforation", the provider clarified it was a laceration.Patient and provider both voiced concern that the laceration might have been caused by vacuum-induced hemorrhage control system (jada system).The patient sought medical attention.No additional adverse event.No product quality complaint reported.Therapy with vacuum-induced hemorrhage control system (jada system) was withdrawn.The outcome of device ineffective was unknown.The causality assessment for uterine cervical laceration was considered as related and for rest events causality was not provided.The event uterine injury, ovarian haematoma, device ineffective and device difficult to use was considered to be serious due to following reason: hospitalization and required intervention (devices).Medical device reporting criteria: serious injury 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.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): 4608 intensive care (patient requires admission to or extension of stay in an intensive care unit.).

• 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: 18660091
• MDR Text Key: 334786052
• Report Number: 3002806821-2024-00003
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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): Required Intervention; Other; Hospitalization
• Patient Sex: Female