MAUDE Adverse Event Report: ORGANON & CO. JADA SYSTEM; INTRAUTERINE VACUUM CONTRACTION SYSTEM

Model Number	JADA-1001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vomiting (2144)
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
This initial spontaneous report originating from the united states was received from a monitor who observed a speaker program, via a company representative, referring to a female patient of unknown age.The patient's concurrent conditions, medical history and past drug reactions/allergies were not reported.No concomitant medications were reported.This report concerns 1 patient and 1 device.On an unknown date, the patient was inserted with vacuum-induced hemorrhage control system ((b)(4) system) (lot# was not reported) for an unknown indication (product used for unknown indication).On an unknown date, the patient experienced vomiting and the device moved (device dislocation).It was stated that the device was removed and replaced with bakri (required intervention).The outcome of vomiting was unknown.The causality assessment was not provided.The availability of the vacuum-induced hemorrhage control system ((b)(4) system) was unknown.Upon internal review, the event device dislocation was determined to be medically significant.Medical device reporting criteria: serious injury.Fda mdr codes: (b)(4).

• Brand Name: JADA SYSTEM
• Common Device Name: 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
• MDR Report Key: 15988486
• Report Number: 3017425145-2022-00150
• Device Sequence Number: 5672624
• Product Code: OQY
• UDI-Device Identifier: 00850017882003
• UDI-Public: (01)00850017882003
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/15/2022

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?: No
• Device Model Number: JADA-1001
• Device Catalogue Number: JADA-1001
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Female