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 01/01/2023

Event Type  Injury  

Event Description

Jada slowed the bleeding but did not completely stop it [device ineffective].Case narrative: this initial spontaneous report originating from the united states was received from a physician via company representative (reported as "msl") referring to a non-pregnant female patient of an unknown age.The patient's medical history included pregnancy and had delivery.The patient's concurrent conditions, and concomitant medications were not reported.This report concerns 1 patient and 1 device.The physician mentioned that she became aware from an obstetrics and gynaecology (obgyn) colleague, not her patient, that on an unknown date in 2023 (reported as "recently"), the patient was inserted with vacuum-induced hemorrhage control system (jada system) for post-partum hemorrhage (postpartum haemorrhage).The vacuum-induced hemorrhage control system (jada system) slowed the bleeding but did not completely stop it (device ineffective).Patient was taken to interventional radiology (ir) for embolization.The patient sought medical attention.The availability of vacuum-induced hemorrhage control system (jada system) was unknown.For vacuum-induced hemorrhage control system (jada system) lot number and serial number were unknown.Upon internal review, the event of device ineffective 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 reporting criteria: serious injury.Fda code: (health effects - health impact per annex f): 4624 surgical intervention (one or more surgical procedures was required, or an existing procedure changed).

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: 16701076
• MDR Text Key: 312877130
• Report Number: 3002806821-2023-00035
• 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: 04/07/2023

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/07/2023
• 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