MAUDE Adverse Event Report: CONVATEC INC CURE PRODUCTS; CATHETER, STRAIGHT

Model Number HM16C

Device Problem Difficult to Remove (1528)

Patient Problem Pain (1994)

Event Type  malfunction  

Event Description

Consumer reports "catheter is difficult to remove and feels "stuck" and takes "firm pressure" to remove." he has been "intermittent catheterizing since the 1990s for neurogenic bladder.Reports established bladder volume of 2l per imaging in the past.He reports he also has dexterity concerns.He is diabetic as well and has some renal impairment and lower extremity edema.He takes lasix.He states despite consistent q 4 hour catheterizations, his urine volume is between 500-1100 ml each time on average.Sometimes the urine volume is 2000 ml at one time.He states on average, it takes 5-10 minutes to drain the bladder once the catheter is inserted and sometimes longer due to both the volume and his dexterity concerns.He states on occasion, the catheter seems "stuck" and it is is "hard to remove" and he has to use "several pounds of firm pressure" to remove the catheter.He is able to remove it and denies any bleeding or obvious trauma to trauma to the penis.Technique was reviewed.Consumer states "he breaks the water sachet and allows it to coat the catheter and allows 20 seconds prior to insertion.He uses either soap and water, baby wipes or alcohol to cleanse the meatus.He hold the penis up and he makes sure the "fin" on the funnel is pointing up and that the coude' tip is pointing up.He reports no resistance during insertion.However, he states after the urine is drained (he either drains into a collection bag or a urinal), the catheter seems stuck and it does not remove easily.

Manufacturer Narrative

A2: sex: male.Based on the available information, this event is deemed to be a reportable malfunction.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number reporting site: (b)(4).Manufacturing site: (b)(4).

• Brand Name: CURE PRODUCTS
• Type of Device: CATHETER, STRAIGHT
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer (Section G): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 17388358
• MDR Text Key: 319697637
• Report Number: 1049092-2023-00226
• Device Sequence Number: 1
• Product Code: EZD
• UDI-Device Identifier: 00815947020352
• UDI-Public: 00815947020352
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: HM16C
• Device Lot Number: 220610-3
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1