MAUDE Adverse Event Report: ORGANON & CO. JADA SYSTEM; INTRAUTERINE VACUUM CONTRACTION SYSTEM

Lot Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

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

Device ineffective [device ineffective] case narrative: this spontaneous report was received from a other healthcare professional clinical education specialist (ces) referring to a non-pregnant female patient of unknown age.The patient's concurrent conditions included postpartum hemorrhage.The patient's medical history included pregnancy, cesarean section of twins.The concomitant medications and past drug reactions/allergies were not reported.This report concerns 1 patient and 1 device.On (b)(6) 2023, the patient inserted with vacuum-induced hemorrhage control system (jada system) via intravaginal route (lot #, serial # and expiration date were not reported) for postpartum hemorrhage indication.The clinical education specialist stated that the patient presented to the emergency room early and ended up having an emergency cesarean section of twins, no further details on this.The clinical education specialist stated that the physician tried medication which failed and then placed vacuum-induced hemorrhage control system (jada system), no further details on this.The clinical education specialist stated vacuum-induced hemorrhage control system (jada system) did not stop bleeding and was removed (device ineffective), and bakri balloon was used which was effective.No further details on this.The patient sought medical attention.The patient lost 4 liters of blood, no further details on this.Patient now fully recovered and breast feeding.Therapy with vacuum-induced hemorrhage control system (jada system) was withdrawn.The outcome of device ineffective was unknown.Upon internal review, the event device ineffective was determined to be medically significant.Medical device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.Fda code: (health effects - health impact per annex f): 4641 unexpected medical intervention (patient required an unforeseen medical intervention, excluding surgery, which was not on the original treatment plan.).

• 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: 18701793
• MDR Text Key: 335300878
• Report Number: 3002806821-2024-00006
• 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: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/14/2024

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 Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2024
• 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?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female