MAUDE Adverse Event Report: ORGANON LLC JADA SYSTEM; INTRAUTERINE VACUUM CONTRACTION SYSTEM

Model Number	JADA-2002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Uterine Perforation (2121)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The model number information was not reported or not known by the reporter hence, we cannot definitively determine the model with the information provided.Model 2 was selected as there is a much higher probability that this model was used as organon is currently only manufacturing/marketing this model.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
They should know about another jada has perforated a uterus [uterine perforation].Case narrative: this spontaneous report originating from united states was received from a consumer referring to a female patient of unknown age.The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.This report concerns 1 patient(s) and 1 device(s).On an unknown date, the patient was placed with the vacuum-induced hemorrhage control system (jada system) 2002 via vaginal route (defaulted) (strength, dose, frequency, lot/batch# number and expiration date were not reported) for an unknown indication.It was reported that, they should know about another vacuum-induced hemorrhage control system (jada system) has perforated a uterus (uterine perforation).She heard this before that a vacuum-induced hemorrhage control system (jada system) caused a perforated uterus.The outcome of uterine perforation was unknown.The reporter considered uterine perforation to be related to vacuum-induced hemorrhage control system (jada system).Upon internal review, the event uterine perforation was determined to be medically significant.This is one of several reports received from the same reporter.Medical device reporting criteria: serious injury.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.

• Brand Name: JADA SYSTEM
• Common Device Name: INTRAUTERINE VACUUM CONTRACTION SYSTEM
• Manufacturer (Section D): ORGANON LLC; 30 hudson street; jersey city NJ 07302
• Manufacturer (Section G): ORGANON LLC; 30 hudson street; jersey city NJ 07302
• Manufacturer Contact: tara brolly ; 30 hudson street; jersey city, NJ 07302
• MDR Report Key: 21917252
• Report Number: 3002806821-2025-00057
• Device Sequence Number: 9031727
• Product Code: OQY
• UDI-Device Identifier: 00840164521139
• UDI-Public: 00840164521139
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K212757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/28/2025

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-2002
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/28/2025
• 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
• Patient Sex: Female