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  

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

It was noted that the uterus had ruptured [uterine rupture] they placed the jada but it didn¿t work [device ineffective].Case narrative: this initial spontaneous report originating from the united states, was received from a physician via clinical educator referring to a female patient of unknown age.The patient's medical history included vaginal birth after cesarean (vbac).The patient's other medical history and concomitant medications were not reported.This report concerns 1 patient and 1 device.On an unknown date, the patient was placed with vacuum-induced hemorrhage control system (jada system) via unknown route (lot# and expiry date not reported) for haemorrhage after a vbac (postpartum haemorrhage) but it did not work (device ineffective) and when they took the patient back to the operating room (or) it was noted that the uterus had ruptured (uterine rupture).Per the provider, they were not sure if vacuum-induced hemorrhage control system (jada system) caused the rupture.The outcome of uterine rupture was unknown.Causality assessment was not provided.The availability of the vacuum-induced hemorrhage control system (jada system) for evaluation was unknown.Upon internal review, the event of device ineffective and uterine rupture were considered to be medically significant.Medical device reporting criteria: serious injury.Fda code: (health effects - health impact per annex f): 4624 (one or more surgical procedures was required, or an existing procedure changed.) 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.Therefore, priority quality investigation will not be completed.

• 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: 16775602
• MDR Text Key: 313640527
• Report Number: 3002806821-2023-00042
• 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: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Patient Sex: Female