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 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

Patient continued to "bleed heavily and fast around the seal" [device ineffective].Case narrative: this initial spontaneous report originating from the united states, was received from a physician via company representative referring to a female patient of unknown age.The patient's current condition included uterine atony, and historical condition included pregnancy and vaginal birth (reported as unsure).Her concomitant drugs included "all the uterotonics" (further unspecified).Her historical drugs and allergies were not reported.This report concerned 1 patient and 1 device.On an unknown date, the patient underwent insertion with vacuum-induced hemorrhage control system (jada system) via an unknown route (lot # and expiration date were not reported) for abnormal postpartum uterine bleeding (postpartum haemorrhage) by the physician, with the suction set at 80 mmhg and 120 ml in the cervical seal, however, the patient continued to "bleed heavily and fast around the seal" (device ineffective).The patient ended up with a hysterectomy.The suspected cause of postpartum haemorrhage was uterine atony.No other information or details were known or available at the time of reporting.It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.Upon internal review, the event of device ineffective was determined to be serious as it 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: 16918489
• MDR Text Key: 315076866
• Report Number: 3002806821-2023-00053
• 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: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• 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
• 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