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 Insufficient Information (4580)

Event Type  Injury  

Event Description

Here jada was used and then a cervical laceration was discovered [uterine cervical laceration] case narrative: this initial spontaneous report originating from the united states was received from physician via clinical education specialist (ces) referring female patient of unknown age.The patient's medical history, concurrent conditions and drug reactions/allergies and concomitant therapies were not reported.On an unknown date, the patient was inserted with vacuum-induced hemorrhage control system (jada system) via intrauterine route, (dose, frequency and lot, expiry date was not reported) for postpartum hemorrhage.This report concerns 1 patient(s) and 1 device(s).The clinical education specialist (ces) stated that there were several cases unknown how many cases or vacuum-induced hemorrhage control system (jada system) devices, where vacuum-induced hemorrhage control system (jada system) was used and then a cervical laceration (uterine cervical laceration) was discovered.The clinical education specialist (ces) reported it felt like it was related to the insertion of the vacuum-induced hemorrhage control system (jada system).The only other detail discussed was that in these cases, the attendee was not sure if the patients were always dilated to 3 cm prior to placement.Number of patients was not known, number of events was not known, number of vacuum-induced hemorrhage control system (jada system) was not known, no further details were discussed, no further details or information was known or available at this time.No additional adverse event (ae) reported, no product quality complaint (pqc) reported.The outcome of uterine cervical laceration was unknown.The causality assessment was not provided.Upon internal review, the event uterine cervical laceration considered to be serious due to following reason: medically significant.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.

• 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: 18354428
• MDR Text Key: 330870491
• Report Number: 3002806821-2023-00137
• 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
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: Yes
• 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
• Patient Sex: Female