MAUDE Adverse Event Report: CONVATEC INC L3C0600 - CURE PRODUCTS

Model Number	510828
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Urinary Tract Infection (2120); Tissue Breakdown (2681)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device 1 of 2.Common device name: cure twist® ¿ ready to use catheter for women.Based on the available information, this event is deemed to be a serious injury.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number (b)(4).
Event or Problem Description
End user states "she has developed several utis over the last few years starting in (b)(6) 2017 after using these catheters because she thinks at times they cut her internally after cathing at times which develops into a uti shortly after, could not quantity all the times this occurred.Most recently she said last week she developed a uti after "drawing blood" with the catheter.She could see visible bright red blood on the catheter as she pulled the catheter out, it stopped shortly after that and then a few days later after another cath the little qty of blood re-started again which also quickly stopped.She is not on blood thinners.She denies seeing any abnormality with the catheter itself.Shortly after those bleeding episodes her usual uti symptoms occurred of cloudy urine, difficulty voiding on her own, frequency, urgency, malodorous urine and pain in bladder and urethra.She called her doctor and she did go do a urine specimen at the lab and they deemed she did have a uti.She was on a course of macrobid antibiotics but then they "switched her to something stronger" and she just finished that antibiotic 2 days ago and feels much better." she also said "she has noted bleeding like this after cathing off/on the last couple years ranging in bleeding episodes ranging from "a little to a lot" after using the t14 and she will get utis often afterwards about "every few months sometimes every month for a stretch" she said.She said she has macrobid on hand and her doctor directed her to take a pill if she ever sees bleeding to prevent utis from forming which has typically worked well for her but sometimes she said she does have to go into the lab to do a urine specimen and get an antibiotic.She said she often got utis when she first learned to cath in (b)(6) 2017 they had her on low dose prophylactic antibiotics but she had to discontinue those due to the side effects.She has a history of kidney stones which she said she passed on her own.Her urologist has already told her if these utis and bleeding events continue the next step is a cystoscopy however she is hesitant and wants to try the smaller size 12 fr catheter first.".

• Brand Name: L3C0600 - CURE PRODUCTS
• 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: 14103319
• Report Number: 1049092-2022-00210
• Device Sequence Number: 6370800
• Product Code: EZD
• UDI-Device Identifier: 00815947020390
• UDI-Public: 00815947020390
• Combination Product (Y/N): N
• PMA/510(K) Number: K072539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/01/2022

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/28/2026
• Device Model Number: 510828
• Device Lot Number: 210808-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female