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); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2024

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 patient continued bleeding around the seal [device ineffective].No additional ae, no pqc reported.[no adverse event].Case narrative: this spontaneous report originating from united states was received from other health care professional (educator) via company representative referring to a female patient of unknown age.The patient¿s historical condition included delivery and pregnancy.The patient¿s concomitant medications and past drug reactions/allergies were not reported.The patient's current condition included lower segment atony.This report concerns 1 patient(s) and 1 device(s).On (b)(6) 2024, the patient was placed with vacuum-induced hemorrhage control system (jada system) via vaginal route (lot #, serial # and expiration date were not reported) for post-partum hemorrhage.On 04-mar-2024, provider placed the vacuum-induced hemorrhage control system (jada system) for post-partum hemorrhage due to lower segment atony.60cc was placed in the cervical seal, and the patient continued bleeding around the seal.The vacuum-induced hemorrhage control system (jada system) was removed, and they moved up their algorithm with treatment.The patient sought medical attention.No product quality complaint (pqc) reported.No additional adverse event (ae) reported (no adverse event).Therapy with vacuum-induced hemorrhage control system (jada system) was discontinued on (b)(6) 2024.Upon internal review, the event device ineffective was determined to be serious due to required intervention (devices).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 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: 18864641
• MDR Text Key: 337188396
• Report Number: 3002806821-2024-00018
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• 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
• Patient Sex: Female