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

Jada attempted and controlled bleeding briefly, new jada that also briefly controlled bleeding and then bleeding resumed.Bakri placed and bleeding continued, to hysterectomy/bleeding did not subside after 5-10 minutes of insertion [device ineffective] case narrative: this initial solicited report was received from a physician referring to a non-pregnant female patient of unknown age who was enrolled in a market research program entitled "jada drivers & barriers qualitative market research" conducted by trinity life sciences.The patient's medical history included pregnancy and had a delivery, her concurrent conditions and drug reactions/allergies were not reported.The patient's concomitant medications included oxytocin (pitocin) and methylergometrine maleate (methergine).This report concerns 1 patient and 2 devices.On an unknown date, the patient was inserted with vacuum-induced hemorrhage control system (jada system) (device number 1) by the physician for bleeding or postpartum uterine bleeding or hemorrhage (postpartum haemorrhage).It controlled bleeding briefly and vacuum-induced hemorrhage control system (jada system) (device number 1) was removed and replaced with a new vacuum-induced hemorrhage control system (jada system) (device number 2) by the physician for bleeding or postpartum uterine bleeding or hemorrhage (postpartum haemorrhage), that also briefly controlled bleeding (also reported as ¿bleeding did not subside after 5-10 minutes of insertion¿ and ¿vacuum-induced hemorrhage control system (jada system) (both devices 1 and 2) did not controlled the bleeding (continued uterine bleeding)¿) and then bleeding resumed (device ineffective).It was reported that bakri placed, and bleeding continued, to hysterectomy which resolved the bleeding.The patient sought medical attention and received treatment (discrepancy: also reported as prescription drug treatment for experience was not required).The patient did not die, no prolonged hospitalization, and no significant disability or incapacity was reported.On an unknown date, therapy with vacuum-induced hemorrhage control system (jada system) (device number 2) was discontinued.The both vacuum-induced hemorrhage control system (jada system) were not available for evaluation since both devices were disposed of after use.For both vacuum-induced hemorrhage control system (jada system), lot number and serial number were not available.Upon internal review, the event of device ineffective was considered as serious due to required intervention.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).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: 16300914
• MDR Text Key: 308824462
• Report Number: 3002806821-2023-00010
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• PMA/PMN Number: 510K K201199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/03/2023

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/04/2023
• 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
• Treatment: METHERGINE (METHYLERGOMETRINE MALEATE),; PITOCIN [OXYTOCIN] (OXYTOCIN),
• Patient Outcome(s): Required Intervention
• Patient Sex: Female