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 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

Vacuum-induced hemorrhage control system (jada system) was removed for an unknown reason and ended up with a hysterectomy [adverse event].Case narrative: this initial spontaneous report originating from the united states was received from a physician via clinical accounts specialist (cas) referring to a non-pregnant female patient of unknown age.The patient's medical history included pregnancy and had delivery; her concurrent conditions, concomitant medication and past/drug allergies were not reported.This report concerns 1 patient and 1 device.On an unknown date, the patient was placed with vacuum-induced hemorrhage control system (jada system) been used with a neptune (waste management system) vaginally (lot# and expiration date were not reported) for postpartum hemorrhage (postpartum haemorrhage).The vacuum-induced hemorrhage control system (jada system) came with blue seal valve, kit, and green carton (2.0).On an unknown date, vacuum-induced hemorrhage control system (jada system) was removed for an unknown reason and ended up with a hysterectomy (adverse event).The patient stated the issue was not related to the vacuum-induced hemorrhage control system (jada system).The patient sought medical attention.No other symptoms and further information was provided.No product quality compliant (pqc) was reported.Outcome of adverse event was unknown.The reporter considered adverse event to be not related to vacuum-induced hemorrhage control system (jada system).Upon internal review, the event of adverse event was considered to be serious due to required intervention.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 serious injury: serious.Fda code (health effects-health impact per annex f): 4624 one or more surgical procedures was required, or an existing procedure changed.Fda code (health effects-health impact per annex f): 4648 (insufficient information)there is not yet enough information available to classify the health impact.

• 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: 16775416
• MDR Text Key: 313636726
• Report Number: 3002806821-2023-00041
• 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: 04/20/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/20/2023
• 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): Required Intervention
• Patient Sex: Female