MAUDE Adverse Event Report: CURE MEDICAL LLC CURE CATHETER COUDE; URINARY CATHETER

Model Number	M14C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	02/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient (user) states he experienced an urinary tract infection because he reused some of the catheters.Patient's doctor instructed him not to do this.Patient received antibiotics and has recovered.

• Brand Name: CURE CATHETER COUDE
• Common Device Name: URINARY CATHETER
• Manufacturer (Section D): CURE MEDICAL LLC; 3471 via lido, #211; newport beach CA 92663
• MDR Report Key: 7463244
• Report Number: 3005471919-2018-00008
• Device Sequence Number: 1482577
• Product Code: GBM
• UDI-Device Identifier: 00815947020086
• UDI-Public: (01)00815947020086(17)220828(10)170926-3(241)M14C
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K072539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 04/24/2018

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: 08/28/2022
• Device Model Number: M14C
• Device Catalogue Number: M14C
• Device Lot Number: 170926-3
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2018
• Initial Report FDA Received Date: 04/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR
• Patient Weight: 110