MAUDE Adverse Event Report: CONVATEC INC L3C0600 - CURE PRODUCTS

Model Number	510813
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Discomfort (2330)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common device name: catheter uretheral.Based on the available information, this event is deemed to be a reportable malfunction.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
Consumer reports using qty 1 ultram12c from a sample pack, lot # 210813-3 and it "felt sharp" in urethra.This was his first time trialing this catheter.He said it felt sharp in his urethra all the way in the insertion and removal of the catheter.He has no allergies he is aware of to lubricant or of any kind.He said it felt sharp, "like it was digging into his urethra." no sharp edges, abnormalities he could see or noted at all with the catheter itself.He mentioned he has very poor eyesight and this catheter is coated in lubricant which would have made it hard to see/ notate abnormalities.He said it felt like the "front leading edge" up near the eyelets is where the felt the sharpness more.He said the discomfort ended as soon as the catheter was removed.Denies any bleeding.No medical intervention sought.He has not had this feeling occur with other catheters.He said the lubricant itself felt dry and thick compared with multiple other catheters he has trialed and he did not like it.He did place the catheter in with the coude tip correctly pointing upwards, making sure blue line was upwards.

• 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: 15051245
• Report Number: 1049092-2022-00312
• Device Sequence Number: 4821716
• Product Code: GBM
• UDI-Device Identifier: 00815947021106
• UDI-Public: 00815947021106
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/28/2024
• Device Model Number: 510813
• Device Lot Number: 210813-3
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2021
• 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: A
• Patient Sequence Number: 1
• Patient Age: 76
• Patient Sex: Male