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 Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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

The "lower uterine segment seemed like it wasn't draining." [device ineffective] 125 cubic centimeter (cc) were inserted into the cervical seal [wrong technique in device usage process] case narrative: this spontaneous report originating from united states was received from a physician via customer account specialist referring to a non-pregnant female patient of unknown age.The patient's historical conditions included pregnancy and vaginal delivery and her concurrent conditions included uterine atony.Her concomitant medications, and drug reactions/allergies were not reported.This report concerns 1 patient and 1 device.On an unknown date, the patient was started on vacuum-induced hemorrhage control system (jada system) via vaginal route (lot# and expiration date were not reported) for post-partum bleeding caused by uterine atony, and she had a dilation and curettage (d&c) and the lower uterine segment seemed like it was not draining (device ineffective) also reported as vacuum-induced hemorrhage control system (jada system) worked without issue, but the bleeding continued.The reporter stated that 125 cubic centimeter (cc) were inserted into the cervical seal (wrong technique in device usage process).An ultrasound was performed, and it showed that the lower uterine segment was bleeding badly.The vacuum-induced hemorrhage control system (jada system) was pulled, and a bakri balloon was put in.It was also reported that the vacuum-induced hemorrhage control system (jada system) came with a blue seal valve with green carton.It was reported that the patient did not die and sought medical attention.No other adverse event (ae) and product quality complaint (pqc) were reported.No additional information was provided.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.Medical device reporting criteria: serious injury.

• 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: 15953401
• MDR Text Key: 305244036
• Report Number: 3002806821-2022-00021
• 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: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female