MAUDE Adverse Event Report: CONVATEC INC L3C0600 - CURE PRODUCTS

Model Number	510801
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	02/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
End userreports that "she developed bleeding while using catheter which required hospitalization.She has been using this catheter for more than a year s/p c4 quadriplegic diagnosis and neurogenic bladder, she reports that on wednesday she developed bright red blood when using catheter.She catheterizes 7 x's per day from her continent diversion stoma.When she catheterized the next time she continued to have bright red blood that filled the collection bag and reports that blood by end of the day appeared darker in color.She was admitted to the hospital for this issue and had a ct scan and ua c and s.Md began iv antibiotics and advised consumer that based on ct scan he believed the catheter eyelets were causing damage to the bladder walls resulting in bleed and infection.She was discharged on saturday and changed to an alternate brand of catheter.Her bleed has resolved.She did not notice anything specifically different in appearance about these catheters but notes that sometimes the french size appears smaller in diameter.She has never measured and all packages are 14french.".

• 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: 13668058
• Report Number: 1049092-2022-00077
• Device Sequence Number: 17392325
• Product Code: FCM
• UDI-Device Identifier: 00815947020673
• UDI-Public: 00815947020673
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K080881
• 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): 02/15/2022

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: 03/28/2024
• Device Model Number: 510801
• Device Lot Number: 210722-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2022
• Initial Report FDA Received Date: 03/04/2022
• 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