MAUDE Adverse Event Report: FOLEY 2-WAY CATHETER STABILIZATION DEVICE (UNKNOWN IF NAME VARIES); HOLDER, URETERAL CATHETER

Device Problem Unintended Movement (3026)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Unreliable: on one, the adhesive was weak in 12 hours and absent in 24.With another, a flap broke off, leaving not enough surface for adhesion.Several with normal adhesion slid down a clean and unwrinkled but unshaved thigh, straightening my indwelling male catheter, so it pulled on the penis, especially when my leg urine bag was filling with up to approximately 2-2.25 pounds of urine.Initially, i did not know about the catheter being anchored with a balloon past my enlarged prostate, so the straightening alarmed me, as i thought that it could pop past the prostate and out of the penis, and i had no plan for that emergency.I walk a lot; my job includes walking and carrying loads.Limited or no availability: pharmacies sent me to surgical supply stores, which found the devices on their computers but said they "can't" get them.I didn't ask why they couldn't get them.Where i asked about a prescription for a cash purchase, it was not required.I apparently can get them from doctors and hospitals, but that's likely too expensive, especially if not available in bulk quantities.I got 3 of the devices from amazon but amazon refused my next order, which was for 6, unless i have a health care license and i agree not to use the devices myself.I don't know why a license should be required by a vendor; they're not difficult to apply.Another vendor sent me 5, but i have to assume more of the devices may be unavailable from anywhere soon for me.Instead of a device, i now use: just as efficacious and safe; easy to buy and use; and cheaper.I've been using for over 2 months, replacing as needed.The arrangement is similar to the design of a garter.I use 3-5 at a time, spread half-way around my thigh to spread the weight on my underpants, threaded through holes in the leg urine bag's upper strap and inside, over, and outside my underpants, and tied with a shoe knot to make untying and retying easy.I leave the device lacking adhesion in place on the catheter but i doubt it serves any purpose that way.The cost for is well under 50 cents for the time period for which an approximately-$(b)(6) device would last.Common sold in dollar stores for packaging is good enough, as sterilization is not needed.I carry precut spare.Fda safety report id # (b)(4).

• Brand Name: FOLEY 2-WAY CATHETER STABILIZATION DEVICE (UNKNOWN IF NAME VARIES)
• Type of Device: HOLDER, URETERAL CATHETER
• MDR Report Key: 14633584
• MDR Text Key: 293710926
• Report Number: MW5110209
• Device Sequence Number: 9
• Product Code: EYJ
• 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: 06/05/2022
• 11 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Treatment: ASPIRIN 325 MG 0-4X/DA; FINASTERIDE; FISH OIL 3600 MG/DA; INDWELLING MALE CATHETER, AND LEG URINE BAG, IN LIEU OF FOLEY 2-WAY CATHETER STABILIZATION DEVICE.; P.R.N. FOR HEADACHE INDUCED BY PROBABLE SINUSITIS (I THINK NONE DURING PRESENT BPH).; TAMSULOSIN; VITAMIN-MINERAL SUPP FOR APPROX. 100% OF DAILY NEEDS IF NEEDS ESTABLISHED
• Patient Outcome(s): Disability
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White