MAUDE Adverse Event Report: GYRUS ACMI INC. 6 X 24 CM DOUBLE PIGTAIL STENT

Model Number 5616024

Device Problem Insufficient Information (3190)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/21/2009

Event Type  Injury  

Event Description

I had surgery in 2009.Doctor left a stent in my ureter.It's a double pigtail 6 x 24 cm stent ref #(b)(4).I am passing small white floating (fiber looking) particles in my urine.I had 2 kidney stone surgeries in 2009 and 1 kidney stone surgery in 2010 by a different doctor.My medical records do not show that it was ever removed and a new doctor was scheduled to do a ct scan, and when i went to this doctor, i was told a ct scan was too much radiation to take.All 3 doctors are associated with the same large company.Thank you, (b)(6).

• Brand Name: 6 X 24 CM DOUBLE PIGTAIL STENT
• Type of Device: 6 X 24 CM DOUBLE PIGTAIL STENT
• Manufacturer (Section D): GYRUS ACMI INC.
• MDR Report Key: 6556907
• MDR Text Key: 74919653
• Report Number: MW5069660
• Device Sequence Number: 1
• Product Code: FAD
• 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: 05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 5616024
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/08/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: 1 CENTRUM SILVER VITAMIN DAILY; ALLOPURINOL 300 MG DAILY; FENOFIBRATE 160 MG DAILY; POTASSIUM CITRATE 1620 MG TWICE DAILY; SERTRALINE 100 MG DAILY
• Patient Outcome(s): Life Threatening
• Patient Age: 73 YR
• Patient Weight: 77