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 Uterine Perforation (2121)

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

Uterine perforation [uterine perforation] jada was placed into a patient using forceps [wrong technique in device usage process].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 concurrent conditions and concomitant medications were not reported.The patient's medical history included dilation and curettage (d&c).This report concerns 1 patient and 1 device.On an unknown date, the patient was inserted with vacuum-induced hemorrhage control system (jada system) for an unknown indication using forceps (wrong technique in device usage process) and there was uterine perforation.The reporter was unsure if that was a result of a d&c.No additional adverse event (ae), no product quality complaint (pqc) reported.No additional information reported.The availability of vacuum-induced hemorrhage control system (jada system) was unknown.For vacuum-induced hemorrhage control system (jada system) lot number and serial number were unknown.The outcome of uterine perforation was unknown.The reporter's causality assessment was not provided.Upon internal review, the event uterine perforation was determined to be 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.Fda code: (health effects - health impact per annex f): 4648 insufficient information (there is not yet enough information available to classify the health impact).

• 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: 16901828
• MDR Text Key: 314902111
• Report Number: 3002806821-2023-00051
• 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: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: 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
• Patient Outcome(s): Other
• Patient Sex: Female