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

Model Number	510863
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Common device name: cure catheter® for men & 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.(b)(4).
Event or Problem Description
End user reports "bleeding with the f14 catheter for the last 3 months.She reports unknown number of catheters, unknown number of market units with unknown lot numbers of the same catheter over the last 3 months." she states "she has used these catheters for many years and never had bleeding with them before this is a new occurrence in the last 3 months.She caths for retention from bladder spasms which she states cause her not to empty her bladder and she caths 6-7 x a day.Phone connection was poor so the information below was all i could obtain.She said the bleeding occurs when she finds it hard to pass the catheter through the sphincter before entering the bladder and she will note discomfort when she removes the catheter.When she looks at the retracted catheter she sees only "a little bit (of blood) in the tube" and states "it is not much".It stops immediately but she will notice this occurs "about every 3rd time" she caths and it is not all the time.She does not think it is a product defect with the catheter but rather an anatomical change of some sort.She said she has never needed to lubricate the catheter prior to insertion as she has never had any issues with this catheter prior inserting it dry." end user was advised we do recommend lubricant with this type of catheter and she can check with her urologist about a lubricant they would recommend for her as lube helps with insertion.She said "she already has some pre-lubricated catheters coming from her supplier to sample.She has always used a size 14 fr for years.We also discussed pelvic floor relaxation techniques as well.She was appreciative of the information.I advised her to see her urologist about this ongoing bleeding and she plans on sending her urologist a message informing her of this change.She last had a cystoscopy with urologist about 4 months ago, prior to when this bleeding started.She said she had a yearly check up about 3-4 weeks ago with her pcp and was found to have a uti.She left a urine sample as part of the yearly check up and it was not performed specifically for the bleeding she clarified.She was having no uti symptoms at the time.She said her md put her on a course of antibiotics for 14 days and she finished them but the bleeding has still persisted as described above about every 3rd time she caths.She is diligent about washing her hands prior to insertion, keeps the catheter sterile and cleanses urethral opening with wipes prior to inserting catheter." end user was advised to follow up with her urologist regarding the bleeding, which she plans on doing.

• Brand Name: CURE PRODUCTS
• Common Device Name: 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: 15477774
• Report Number: 1049092-2022-00370
• Device Sequence Number: 20294863
• Product Code: EZD
• UDI-Device Identifier: 00815947020215
• UDI-Public: 00815947020215
• 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): 09/21/2022

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 Model Number: 510863
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 09/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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