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

New jada that also briefly controlled bleeding/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 via c-section (caesarean section), 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 1 device.On an unknown date, the patient was inserted with new vacuum-induced hemorrhage control system (jada system) by the physician for bleeding or postpartum uterine bleeding or hemorrhage (postpartum haemorrhage).The physician reported that the patient was not her patient, and it was her partner who said to her about the patient.It controlled bleeding briefly (also reported as ¿bleeding did not subside after 5-10 minutes of insertion¿ and ¿vacuum-induced hemorrhage control system (jada system) did not control the bleeding (continued uterine bleeding)¿) (device ineffective) and then bleeding resumed.Vacuum-induced hemorrhage control system (jada system) was removed.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.The vacuum-induced hemorrhage control system (jada system) was not available for evaluation since it was disposed of after use.For 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.This case has been cross referenced with oars# (b)(4) (same patient).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).The follow-up information has been submitted to the original case, oars# (b)(4).

• 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: 16546104
• MDR Text Key: 311328161
• Report Number: 3002806821-2023-00026
• 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: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2023
• 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
• 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