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

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

Patient Problems Hemorrhage/Bleeding (1888); Thrombosis/Thrombus (4440)

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

Clots and bleeding in the fundus [thrombosis].On arrival it was discovered that patient was bleeding [device ineffective].Case narrative: this spontaneous report originating from united states was received from a physician via clinical educator, referring to a non-pregnant female patient of unknown age.The patient's medical history included pregnancy, vaginal twin delivery, retained placenta (also reported as parts) which was removed, and her current conditions included uterine atony.Her concomitant medications, and past drug reactions/allergies were not reported.This report concerns 1 patient and 1 device.On an unknown date, the patient was inserted with vacuum-induced hemorrhage control system (jada system) intravaginally for postpartum hemorrhage (postpartum haemorrhage) by the physician in the operating room (or).It was reported that the vacuum-induced hemorrhage control system (jada system) worked for 20 minutes in the or with estimated blood loss of about 50 "qvl¿ and was capped for transfer to patient room.On arrival it was discovered that the patient was bleeding (device ineffective).A sonogram was performed which showed clots (thrombosis) and bleeding in the fundus.The vacuum-induced hemorrhage control system (jada system) was removed and replaced with a bakri which controlled the hemorrhage.Total "evl" was 7000 per clinical educator.It was also reported that no interventions were given prior to the use of vacuum-induced hemorrhage control system (jada system).More than 1 device was not used.The device was not removed and the re-inserted again.Disseminated intravascular coagulation (dic) was not diagnosed.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 not provided.The outcome of thrombosis was unknown.The reporter's causality assessment was not provided.Upon internal review, the event of thrombosis was determined to be medically significant.Upon internal review, the event of device ineffective was considered as 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): 4642 additional device required (use of an additional or alternative device require to achieve optimal outcome).

• 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: 17018614
• MDR Text Key: 316121412
• Report Number: 3002806821-2023-00065
• 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: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• 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; Other
• Patient Sex: Female