MAUDE Adverse Event Report: CONVATEC CURE PRODUCTS; CATHETER, UROLOGICAL

Model Number	ULTRA M14
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Tissue Breakdown (2681)
Type of Reportable Event	Malfunction
Event or Problem Description
End user states with these catheters he would note hurt with insertion and he would see blood at the tip of the catheter upon retraction.It was a small amount on on catheter tip and would stop immediately.He said the tips of those felt "too sharp on the end" compared to the others he had used and thinks they cut him inside urethra.He said the defect was visible after examination.This emdr is to address sharp edges.
Additional Manufacturer Narrative
A2: age: 65, sex: male.D2: common device name: catheter, urological.E1: patient country: (b)(6).G1: complainant phone: (b)(6).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.This complaint has been evaluated.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.Fda registration number: reporting site: 1049092.Manufacturing site: 3005471919.

• Brand Name: CURE PRODUCTS
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): CONVATEC; 7815 national service road; suite 600; greensboro NC
• Manufacturer (Section G): CONVATEC; 7815 national service road; suite 600; greensboro NC
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 17135509
• Report Number: 1049092-2023-00172
• Device Sequence Number: 3930847
• Product Code: KOD
• UDI-Device Identifier: 00815947021069
• UDI-Public: 00815947021069
• Combination Product (Y/N): N
• PMA/510(K) Number: K221593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/05/2023

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 Model Number: ULTRA M14
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2023
• Initial Report FDA Received Date: 06/15/2023
• 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: Unknown