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 Coagulation Disorder (1779)

Event Date 11/01/2022

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

But it failed in treating the bleeding for the patient's postpartum primary hemorrhage [device ineffective].The patient was coagulopathic [coagulopathy].Case narrative: this spontaneous report was received from a physician via company representative referring to a female patient of unknown age.The patient's historical conditions included pregnancy (also reported as "pregnant: yes"; discrepant information) and vaginal delivery.Her concurrent conditions, concomitant medications, and allergies were not reported.This report concerns 1 patient and 1 device.Approximately on an unknown date in (b)(6) 2022 (reported as "sometime last week"), the patient was started on vacuum-induced hemorrhage control system (jada system) via vaginal route for post-partum primary hemorrhage (postpartum haemorrhage (primary)) (lot# and expiration date were not reported).The reporter stated that it sounded like everything went right with the actual device, but it failed in treating the bleeding for the patient's postpartum primary hemorrhage (device ineffective, onset date: unknown date in (b)(6) 2022).The patient was coagulopathic (coagulopathy), but it was unknown if this was discovered prior to vacuum-induced hemorrhage control system (jada system) use or after.It was also reported that for some reason the staff using it were concerned that blood went into the cannister and weren't sure if something was wrong with the device, but the healthcare professional (hcp) told them that it was normal.The patient ended up getting a hysterectomy (also reported as treatment), but other details of the patient's outcome were unknown.It was also reported that the patient sought medical attention and the patient did not die.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.The action taken with vacuum-induced hemorrhage control system (jada system) with respect to the event of coagulopathy was reported as withdrawn approximately on an unknown date in (b)(6) 2022.The outcome of coagulopathy was unknown.The causality assessment between the event of coagulopathy and vacuum-induced hemorrhage control system (jada system) was not provided.Upon internal review, the event of "device ineffective" was determined to be serious as it required intervention.Medical device reporting criteria: serious injury.(b)(4).

• 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: 15879913
• MDR Text Key: 304463640
• Report Number: 3002806821-2022-00015
• 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: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female