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 11/01/2023

Event Type  Injury  

Event Description

When the health care professional (hcp) went to remove the device, that she started bleeding again [haemorrhage] jada did control the bleeding with an additional ebl of 300 ml [device ineffective] case narrative: this spontaneous report originating from united states was received from a consumer via clinical educator (ce), referring female patient of unknown age.The patient's concurrent conditions included postpartum hemorrhage.The patient's historical condition included pregnancy.The concomitant medications and past drug reactions/allergies were not reported.This report concerns 1 patient(s) and 1 device(s).On unknown date, the patient underwent insertion with vacuum-induced hemorrhage control system (jada system) via intravaginal route (lot #, serial # and expiration date were not reported) for postpartum hemorrhage indication.(b)(6) 2023 the patient had a c-section, and the insertion with vacuum-induced hemorrhage control system (jada system) device was placed in the recovery room.Ce unsure if/what medications were administered prior to placement of insertion with vacuum-induced hemorrhage control system (jada system).At time of placement, the patient had an ebl of 2 to 3 liters.Insertion with vacuum-induced hemorrhage control system (jada system) did control the bleeding with an additional estimated blood loss (ebl) of 300 ml (device ineffective).It remained in place for approximately 8 hours.When the health care professional (hcp) went to remove the device, that she started bleeding again (bleeding), was taken to the operating room and blood was noted to be in her abdomen.Sought medical attention.Hysterectomy was performed and patient was admitted to the intensive care unit (icu).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.

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.

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

When the health care professional (hcp) went to remove the device, that she started bleeding again [haemorrhage].Jada did control the bleeding with an additional ebl of 300 ml [device ineffective].Case narrative: this initial spontaneous report originating from the united states was received from healthcare provider via clinical educator (ce) referring female patient of unknown age.The patient's concurrent conditions included postpartum hemorrhage.The patient's historical condition included pregnancy and cesarean section.The concomitant medications and past drug reactions/allergies were not reported.This report concerns 1 patient(s) and 1 device(s).On an unknown date in (b)(6) 2023 (reported as last week), the patient underwent insertion with vacuum-induced hemorrhage control system (jada system) via intravaginal route (lot #, serial # and expiration date were not reported) for postpartum hemorrhage indication.On an unknown date in (b)(6) 2023 (reported as last week), at the time of placement, the patient had an estimated blood loss of 2 to 3 liters.Insertion with vacuum-induced hemorrhage control system (jada system) did control the bleeding with an additional estimated blood loss (ebl) of 300 ml (device ineffective).It remained in place for approximately 8 hours.When the health care professional (hcp) went to remove the device, that she started bleeding again (haemorrhage), was taken to the operating room and blood was noted to be in her abdomen.Caller was unsure if/what medications were administered prior to placement of insertion with vacuum-induced hemorrhage control system (jada system).The patient sought medical attention.Hysterectomy was performed and patient was admitted to the intensive care unit (icu).Therapy with vacuum-induced hemorrhage control system (jada system) was withdrawn.The outcome of device ineffective and haemorrhage was unknown.The causality assessment was not provided.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 to be medically significant and event haemorrhage was considered as serious due to the required intervention.Fda code: (health effects - health impact per annex f): 4624 surgical intervention (one or more surgical procedures, including percutaneous or minimally invasive procedures, were required, or an existing procedure changed).Fda code: (health effects - health impact per annex f): 4608 intensive care (patient requires admission to or extension of stay in an intensive care unit.) 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.This is an amended report to update the additional health impact code of ¿intensive care¿ since the patient was admitted to the icu and clinical signs imdrf code for event device ineffective.Event type updated to ¿patient event¿ and as reported causality updated to unknown for event haemorrhage.Product problem checkbox was checked under medwatch information.

• 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: 18192928
• MDR Text Key: 328814265
• Report Number: 3002806821-2023-00135
• 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,Followup
• Report Date: 12/15/2023

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: 11/22/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/15/2023
• 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): Hospitalization; Other; Required Intervention
• Patient Sex: Female