MAUDE Adverse Event Report: UNKNOWN FOLEY CATHETER; CATHETER, RETENTION TYPE, BALLOON

Patient Problems Bruise/Contusion (1754); Micturition Urgency (1871); Pain (1994); Urinary Retention (2119); Discomfort (2330); Sleep Dysfunction (2517); Constipation (3274)

Event Date 11/17/2023

Event Type  Injury  

Event Description

Botox injections to treat overactive bladder.Overactive urge to urinate remained severe and ability became constipated.Had to wear foley catheter for a week.Catheter caused great discomfort and terror.Could barely sleep.Afraid leg bag would overflow.Repeated nocturnal penile tumescence with catheter caused painful erections and insomnia.Also suffered painful bruising on the tip of my penis.Way too uncomfortable to wear catheter at my job, especially with my other health issues.Had to miss work and walk with a walker to avoid putting too much weight on midsection when walking.Could not switch between daytime and nighttime bags because connection was too tight.Emergency room refused to catheterize me for urinary retention.They made me wait and try desperately to urinate for hours.Hospitals don't admit you to assist with catheter management.Had to wait extra-long for follow up with urologist.Don't have all the answers to this problem, but do have some ideas.Doctor should have offered spc catheter or an alternative to botox entirely.Would ask that you please rethink your approval of botox for treating overactive bladder, or at least approve medication such as lupron, including insurance coverage if that's also in your scope, to suppress erections in cases where foley catheter is necessary.Botox for bladder only made it harder to urinate and did not take away the overactive discomfort in urinary tract or penis that was causing the problem.This was the same effect as medications such as oxybutynin and myrbetriq.Botox treatment should be planned differently or rescinded for overactive bladder.Coverage and approval for supplemental treatment to suppress erections would make a lot of sense to me too.Thank you for your time and consideration!.

• Brand Name: FOLEY CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 19116801
• MDR Text Key: 340540135
• Report Number: MW5153887
• Device Sequence Number: 1
• Product Code: EZL
• 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: 04/12/2024

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/15/2024
• Patient Sequence Number: 1
• Treatment: BOTOX.; MYRBETRIQ.; OXYBUTYNIN.
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 128 KG