MAUDE Adverse Event Report: ORGANON LLC JADA; INTRAUTERINE TAMPONADE BALLOON

Patient Problem Distress (2329)

Event Date 11/03/2023

Event Type  Injury  

Event Description

Jada hemorrhage device placed but did not control bleeding.Was told this device never fails and website claims 94% success yet customer footing bill of device needed in crisis with no time to make informed decision.Clinical trial on only 107 people.Device needed to save life yet not covered by insurance and failure resulting in need for additional intervention.Emotional distress from incident.

• Brand Name: JADA
• Type of Device: INTRAUTERINE TAMPONADE BALLOON
• Manufacturer (Section D): ORGANON LLC
• MDR Report Key: 18797646
• MDR Text Key: 336565420
• Report Number: MW5152046
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White