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 11/10/2023

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

Did not control the bleeding [device ineffective] case narrative: this spontaneous report originating from united states was received from a consumer via clinical educator (ce), referring to a 21-year-old female patient.The patient's concurrent conditions included postpartum hemorrhage.The concomitant medications and past drug reactions/allergies were not reported.This report concerns 1 patient and 1 device.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.On (b)(6) 2023, the patient experienced postpartum hemorrhage after delivery, sought medical attention that none of the medications administered worked (medications given were unknown), vacuum-induced hemorrhage control system (jada system) was inserted but did not control the bleeding (device ineffective), and care was escalated to hysterectomy.The patient was not doing well.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.

Event Description

Did not control the bleeding [device ineffective].Case narrative: this spontaneous report originating from united states was received from a consumer via clinical educator (ce), referring to a 21-year-old non pregnant female patient.The patient's concurrent conditions included postpartum hemorrhage.The concomitant medications and past drug reactions/allergies were not reported.This report concerns 1 patient and 1 device.On (b)(6) 2023, 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 (b)(6) 2023, the patient experienced postpartum hemorrhage after delivery that none of the medications administered worked (medications given were unknown), vacuum-induced hemorrhage control system (jada system) was inserted but did not control the bleeding (device ineffective), and care was escalated to hysterectomy.The patient was not doing well.The patient sought medical attention.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.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 amended report to check product problem checkbox.

• 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: 18171055
• MDR Text Key: 328545308
• Report Number: 3002806821-2023-00134
• 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: Consumer,Company Representative
• Reporter Occupation: Other
• 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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/20/2023
• 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): Required Intervention
• Patient Age: 21 YR
• Patient Sex: Female