MAUDE Adverse Event Report: FOSSA MEDICAL INC RENAL UROLOGY STENT K072293; URETERAL STENT

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Pain (1994); Urinary Tract Infection (2120); Hematuria (2558)

Event Type  Other  

Event Description

Re: ureteral stents for treatment of urinary obstructions.I have read all of your information on the ureteral stents, double j stents, gibbons pyelostomys, open 8" stents.But i find nothing about the side effect people will have with them in their bladder.So, i am going to tell you about the side effects that my husband had with them.(b)(6) had several ureteral stents put in his bladder due to bladder cancer.You can't have anything with caffeine in it, which is no coffee, tea, chocolate, etc.Because it gives you bladder pains.And another side effect from the stents is bladder infections, and you also, have blood in your urine.From the stent rubbing in your bladder.And you can't lift heavy items, either.And you have to go to your bladder doctors for recheck.X-rays to make sure the stent was still in the same place that it was put into.And if doctor takes the stent out too early after bladder cancer surgery, the kidney will close up.Which happened to my husband back in 2009.When, (b)(6) went for his bladder cancer recheck in 2010, his bladder doctor found some tumors that had to be removed, which the surgery doctor did.Also, due to removing the stent too early, (b)(6) 's right kidney closed up and he had to have another surgery on his right kidney to open it back up again.So, dr.(b)(6) had to put a new stent in.(b)(6) had to have it in for a year to make sure the right kidney, would heal and stay open.The urine stent helps patients, but there are side effects too, from them.It said that you try the stent on (b)(6).Nothing was mentioned about people up in age.Like in their 70's.Since, my husband is deceased, i have time on my hands to read up on urine stent, and some of his cancer treatments things that was given to him.When he was fighting cancer.I just want to let you folks know that there are side effects from the urine stents.Sincerely, mrs (b)(6).P.S.If my husband had problems with these urine stents, i'm sure other people are having the same problems, and don't know who to talk to beside the bladder doctor.

• Brand Name: RENAL UROLOGY STENT K072293
• Type of Device: URETERAL STENT
• Manufacturer (Section D): FOSSA MEDICAL INC
• MDR Report Key: 3750150
• MDR Text Key: 19804269
• Report Number: MW5035606
• 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: Other
• Type of Report: Initial
• Report Date: 04/03/2014

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?: No
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/10/2014
• Patient Sequence Number: 1