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); 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

Was bleeding too fast the jada would not stay in [device difficult to use] no additional ae reported [no adverse event] case narrative: this spontaneous report originating from united states was received from a physician via clinical educator (ce) referring to a 45-year-old female patient.The patient¿s historical condition included delivery, gravidity 2 and parity 1.The patient¿s current condition, 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) (lot #, serial # and expiration date were not reported) via vaginal route for postpartum hemorrhage.On an unknown date, it was reported that the patient recently with a 5000 ml total blood loss.The vacuum-induced hemorrhage control system (jada system) was placed approximately 2 hours after delivery and the patient was bleeding too fast the vacuum-induced hemorrhage control system (jada system) would not stay in (device difficult to use).It was reported that they used all the medications (specific medications not provided), transfused and did a hysterectomy, the patient sought medical attention, and this was the patient's second baby, she was transferred from the icu (intensive care unit) to a high-level facility.Vacuum-induced hemorrhage control system (jada system) device did not stop control the bleeding.It was reported that icu required for maternal admission.Blood products required during peripartum period.No additional ae (adverse event) reported (no adverse event), no pqc (product quality complaint) reported.Therapy with vacuum-induced hemorrhage control system (jada system) was withdrawn.The outcome for device difficult to use was unknown.The causality assessment was not provided.Upon internal review, the event device difficult to use was determined to be serious due to required intervention (devices) and 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): 4643 blood transfusion (patient required an infusion of whole blood or a blood component directly into the bloodstream.) 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.) 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).

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

Was bleeding too fast the jada would not stay in [device difficult to use] no additional ae reported [no adverse event] case narrative: this spontaneous report originating from united states was received from a physician via clinical educator (ce) referring to a 45-year-old female patient.The patient¿s historical condition included delivery, gravidity 2 and parity 1.The patient¿s current condition, 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) (lot #, serial # and expiration date were not reported) via vaginal route for postpartum hemorrhage.On an unknown date, it was reported that this was the patient's second baby.There was a total blood loss of 5000 ml.The vacuum-induced hemorrhage control system (jada system) was placed approximately 2 hours after delivery.The patient was bleeding too fast the vacuum-induced hemorrhage control system (jada system) would not stay in (device difficult to use).Medical attention was sought.¿all medications¿ (unspecified) were used, transfusion (blood products were used in the peripartum period) and hysterectomy were done.Patient was transferred from the icu (intensive care unit) to a high-level facility for maternal admission.No additional ae (adverse event) reported (no adverse event), no pqc (product quality complaint) reported.Therapy with vacuum-induced hemorrhage control system (jada system) was withdrawn.The outcome for device difficult to use was unknown.The causality assessment was not provided.Upon internal review, the event device difficult to use was determined to be serious due to required intervention (devices) and 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): 4643 blood transfusion (patient required an infusion of whole blood or a blood component directly into the bloodstream.) 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.) 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).This is an amendment report: captured treatment received as yes for event device difficult to use, updated narrative in clear and concise manner and additional seriousness criteria as hospitalization was added for event device difficult to use.

• 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: 18797851
• MDR Text Key: 336446224
• Report Number: 3002806821-2024-00011
• 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: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• 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): Other; Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female