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

Model Number	M12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	11/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
User's technique may have caused or contributed to the adverse event.User reported he was not cleaning the insertion area before insertion.In addition, he reported he was inserting the catheter into a lubricant tube prior to insertion and then reusing the same lubricant tube.He was sent an instruction guide and encouraged to discuss technique with his doctor.
Event or Problem Description
Intermittent catheter patient (user) reported experiencing a recurrent urinary tract infection (uti).He was prescribed three rounds of antibiotics which at the time of the last communication had been unsuccessful at totally clearing the infection.No device defect or malfunction was reported.

• 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: 9781577
• Report Number: 3005471919-2020-00008
• Device Sequence Number: 16841095
• Product Code: EZD
• UDI-Device Identifier: 00815947020024
• UDI-Public: (01)00815947020024(17)240628(10)190715-3(241)M12
• 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): 03/03/2020

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: 06/28/2024
• Device Model Number: M12
• Device Catalogue Number: M12
• Device Lot Number: 190715-3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 03/03/2020
• 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: 49 YR
• Patient Weight: 68