MAUDE Adverse Event Report: CONVATEC INC L3C0600 - CURE PRODUCTS

Model Number	510824
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Urinary Tract Infection (2120); Hematuria (2558)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Common device name: cure ultra® ready-to-use catheter for women.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.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
It was reported by product end user to product distributor that when she used the catheter she "spotted" blood on the catheter during catheterization.The end user reports she developed a urinary tract infection which she attributes to the catheter.Per the end user her urine became "cloudy and odorous and she had a burning sensation to the urethra".End user states her healthcare provider did a urinalysis and culture and was "positive for infection".The end user was prescribed "cipro", she reports her symptoms resolved.There was no known malfunction reported for the cause of infection.No photographs or laboratory documentation depicting the reported complaint issue.Lot unknown.

• 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: 13308962
• Report Number: 1049092-2022-00007
• Device Sequence Number: 4964813
• Product Code: EZD
• UDI-Device Identifier: 00815947020451
• UDI-Public: 00815947020451
• 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): 12/21/2021

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: 510824
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 01/20/2022
• 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