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

Model Number	M14U
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	12/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Intermittent catheter patient (user) reported experiencing a recurrent urinary tract infection (uri) for 6-8 weeks.Due to his history with recurrent uti his doctor prescribed ciprofloxacin to take when he felt symptoms coming on.Patient stated that he would take the ciprofloxacin for about a week and uti symptoms would go away but then reoccur several times before finally clearing up.

• Brand Name: CURE CATHETER
• Common Device Name: URINARY CATHETER
• Manufacturer (Section D): CURE MEDICAL LLC; 3471 via lido, #211; newport beach, ca
• MDR Report Key: 9775262
• Report Number: 3005471919-2020-00006
• Device Sequence Number: 19476503
• Product Code: EZD
• UDI-Device Identifier: 00815947020123
• UDI-Public: (01)00815947020123(17)240428(10)190521-2(241)M14U
• Combination Product (Y/N): N
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/26/2020

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: 04/28/2024
• Device Model Number: M14U
• Device Catalogue Number: M14U
• Device Lot Number: 190521-2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 03/02/2020
• 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: 68 YR
• Patient Weight: 79