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 08/24/2023

Event Type  Injury  

Event Description

Her bleeding was not well controlled with the device so she progressed to having a hysterectomy [device ineffective].Case narrative: this spontaneous report originating from united states was received from a physician via company representative and designated point of contact (dpoc), referring to a female patient of unknown age.The patient's medical conditions included pregnancy and delivery and her current condition included uterine atony.Her past drugs/allergies and concomitant medications were not reported.This report concerns 1 patient and 1 device.On (b)(6) 2023 (thursday), the patient was placed with vacuum-induced hemorrhage control system (jada system) via intrauterine route for postpartum bleeding control by the attending physician, however, her bleeding was not well controlled with the device so she progressed to having a hysterectomy (device ineffective).Reportedly, the incident occurred overnight and the device was removed on (b)(6) 2023 (friday).The suspected cause of the postpartum hemorrhage was reported as uterine atony.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.Medical device reporting criteria: serious injury.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.(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: 17660313
• MDR Text Key: 322365268
• Report Number: 3002806821-2023-00105
• 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: 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
• Device Operator: Health Professional
• 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