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 Hemorrhage/Bleeding (1888)

Event Date 08/25/2023

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

Jada was inserted but did not control the bleeding [device ineffective].Patient had ¿a lot of clots in the uterus¿ and provider believes that may be why the device did not control the bleeding properly.[wrong technique in device usage process] case narrative: this spontaneous report originating from united states was received from a healthcare professional via company representative, referring to a female patient of unknown age.The patient's medical history included pregnancy and on (b)(6) 2023, she experienced excess bleeding after a cesarean section.Her past drugs/allergies and concomitant medications were not reported.This report concerns 1 patient and 1 device.On (b)(6) 2023, the patient was placed with vacuum-induced hemorrhage control system (jada system) via intrauterine route for postpartum bleeding by an unspecified provider, however, it did not control the bleeding (device ineffective).Reportedly, the patient had "a lot of clots in the uterus" (considered as current condition) and provider believed that might be why the device did not control the bleeding properly (wrong technique in device usage process).Patient was sent to interventional radiology for bilateral embolization.At the time of reporting, the patient's condition was recovering.It was also reported that more than one device was not used.It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.For vacuum-induced hemorrhage control system (jada system), the lot number and the serial number were not available.Upon internal review, the event of device ineffective was considered as serious due to the 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).

• 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: 17661144
• MDR Text Key: 322386335
• Report Number: 3002806821-2023-00106
• 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: 08/31/2023

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: 08/31/2023
• 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