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

Model Number	ULTRA M16C
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
A nurse has also advised the patient on techniques to reduce the probability of catheterization related infection.
Event or Problem Description
Patient (user) reported he contracted a urinary tract infection.Symptoms continued to reoccur periodically despite several antibiotic treatments.During his most recent urology visit his doctor advised more frequent catheterization and to expect a urinary tract infection to occur from time to time as a result of catheterization in general.

• Brand Name: CURE MALE ULTRA
• Common Device Name: URINARY CATHETER
• Manufacturer (Section D): CURE MEDICAL LLC; 3471 via lido, #211; newport beach CA 92663
• MDR Report Key: 9679414
• Report Number: 3005471919-2020-00004
• Device Sequence Number: 16739945
• Product Code: KOD
• UDI-Device Identifier: 00815947021120
• UDI-Public: (01)00815947021120(17)220528(10)190602-7(241)ULTRAM16C
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K080881
• 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): 02/06/2020

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: 05/28/2022
• Device Model Number: ULTRA M16C
• Device Catalogue Number: ULTRA M16C
• Device Lot Number: 190602-7
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 02/06/2020
• 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: 66 YR
• Patient Weight: 100