MAUDE Adverse Event Report: CONVATEC INC L3C0600 - CURE PRODUCTS

Model Number	510816
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
Event or Problem Description
End user reports "his first uti while cathing and was using this catheter.He said he went into his pcp for regular examination last week, having no uti symptoms, and they did a routine urinalysis which was positive for uti he said.His pcp consulted with his urologist and he was told this infection was due to catheterization.He is unsure if a urine culture was done but he was put on a treatment course of ciprofloxacin he said which he is still finishing up." he states he has "only been using the ultram16 for the past 2 months because his other catheters were unavailable.He started cathing about 1-2 years ago he said after a knee operation he which resulted in urinary retention as while he was post op and resulted in sepsis due to the urine he said.Ever since then he caths nightly per his urologist and was told to monitor so he gets out between 50-100ml nightly which his urologist is happy with.Throughout the day he voids on his own.He makes sure to stay well hydrated.He has regular bowel movements.His wife typically caths for him and she washes her hands prior to cathing.Makes sure the catheter stays sterile and does wipe meatus with an antibacterial wipe prior to placement.Denies any difficulty with placing this catheter or pain/discomfort at all.".
Additional Manufacturer Narrative
Common device name: cure ultra® ready-to-use catheter for men.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).

• 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: 14619741
• Report Number: 1049092-2022-00297
• Device Sequence Number: 11876140
• Product Code: OHR
• UDI-Device Identifier: 00815947021076
• UDI-Public: 00815947021076
• 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): 06/03/2022

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: 10/28/2024
• Device Model Number: 510816
• Device Lot Number: 211110-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2021
• 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: Male