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

Lot Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

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

Jada was used, and it wasn't successful [device ineffective] no other ae reported, no pqc reported [no adverse event] case narrative: this spontaneous report originating from united states was received from physician via clinical sales educator referring to a female patient of unknown age.The patient's medical history, past drugs or allergies, and concomitant medications were not reported.This report concerns 1 patient(s) and 1 device(s).On an unknown date, the patient was inserted with the vacuum-induced hemorrhage control system (jada system) via vaginal route (batch/lot# and expiry date were not reported) for an unknown indication.The clinical sales educator reporting on behalf of the physician.On 01-feb-2024, the clinical sales educator reported that she was speaking with the safety officer of the facility.The clinical sales educator reported the safety officer said she saw in a chart review that a vacuum-induced hemorrhage control system (jada system) was used, and it was not successful (device ineffective), so it was taken out and vaginal packing was used.The clinical sales educator reported there was no mention that they believed there was an issue with the product itself.She had a contact number for the safety officer (see case contacts) but did not have confirmed contact information for the physician.The patient sought medical attention.She had no further information to provide.No other adverse event (ae) or product quality complaint (pqc) reported (no adverse event).Therapy with vacuum-induced hemorrhage control system (jada system) was withdrawn.The outcome of device ineffective was unknown.Upon internal review, the event device ineffective was determined to be medically significant.Medical device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.Fda code: (health effects - health impact per annex f): 4648 insufficient information (it is not clear whether any health impact occurred, or health impact appears to have occurred, but 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: 18666854
• MDR Text Key: 334841865
• Report Number: 3002806821-2024-00005
• 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: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Lot Number: UNKNOWN
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female