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 04/06/2023

Event Type  Injury  

Event Description

Unable to insert the jada system [device use issue].Case narrative: this initial spontaneous report originating from the united states was received from a physician referring to a non-pregnant female patient of unknown age.The patient's concurrent condition included hospitalization.The patient's medical history included pregnancy and had scheduled caesarean section.The patient's concomitant medications were not reported.This report concerns 1 patient and 1 device.On (b)(6) 2023, the patient was inserted with vacuum-induced hemorrhage control system (jada system) via intravaginal route for hemorrhage (postpartum haemorrhage) by the physician.The physician stated that she was unable to insert the vacuum-induced hemorrhage control system (jada system) (device use issue) stating she felt the patient was not dilated enough and that the cervix was thin, and she was afraid she would tear it.The patient's hospitalization was prolonged due to the event.On (b)(6) 2023, therapy with vacuum-induced hemorrhage control system (jada system) was discontinued.The patient sought medical attention and she was stable now.No product quality complaint (pqc) reported.The vacuum-induced hemorrhage control system (jada system) was not available for inspection as it was discarded.For vacuum-induced hemorrhage control system (jada system) lot number and serial number were unknown.Medical device reporting criteria: serious injury fda code: (health effects - health impact per annex f): 4648 insufficient information (there is not yet enough information available to classify the health impact) fda code: (health effects - health impact per annex f): 4641 patient required an unforeseen medical intervention, excluding surgery, which was not on the original treatment plan.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: 16725566
• MDR Text Key: 313165312
• Report Number: 3002806821-2023-00039
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2023

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/12/2023
• 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): Hospitalization
• Patient Sex: Female